Zimmer Periarticular Distal Lateral Fibular Locking Plates. Surgical Technique IMAGE TO COME. Designed to optimize placement and fixation

Transcription

1 Zimmer Periarticular Distal Lateral Fibular Locking Plates Surgical Technique IMAGE TO COME Designed to optimize placement and fixation

2

3 Zimmer Periarticular Plates Surgical Technique Zimmer Periarticular Distal Lateral Fibular Locking Plates Surgical Technique Developed in conjunction with: Stephen K. Benirschke, M.D. Professor, Department of Orthopaedics and Sports Medicine Associate Professor, Orthopaedics University of Washington Harborview Medical Center Seattle, Washington Paul J. Duwelius, M.D. Adjuvant Associate Professor Orthopaedics Oregon Health Sciences University Clinical Attending St. Vincent Hospital & Medical Center Portland, Oregon James A. Goulet, M.D. Professor and Director Section of Orthopaedic Trauma Department of Orthopaedic Surgery The University of Michigan Hospitals Ann Arbor, Michigan David A. Templeman, M.D. Associate Professor Orthopaedic Surgery University of Minnesota Staff, Hennepin County Medical Center Minneapolis, Minnesota Robert A. Winquist, M.D. Clinical Professor University of Washington Orthopaedic Surgeon Swedish Hospital and Medical Center Seattle, Washington Table of Contents Introduction Locking Screw Technology Locking Plate Technology Plate Features Indications Fracture Classification Surgical Technique 5 Required Instrumentation 5 Preoperative Preparation 5 Surgical Approach 5 Fracture Reduction 5 Plate Positioning 5 Screw Selection 7 Fracture Fixation 7 Wound Closure 0 Postoperative Treatment 0 Surgical Pearls 0 Instruments and Implants

4 Zimmer Periarticular Plates Surgical Technique Introduction The Zimmer Periarticular Locking Plate System combines locking screw technology with periarticular plates to create fixed-angle constructs for use in multifragmentary fractures or where deficient bone stock or poor bone quality is encountered. The fixed-angle plate/ screw device can be used in osteopenic bone and other areas where traditional screw fixation may be compromised. The Periarticular Locking Plates will accommodate standard screws, as well as locking screws with threaded heads that allow the screw to be locked into position to facilitate proper plate/ screw placement. When necessary, interfragmentary compression can be achieved with lag screws. The plate configuration contains locking screw holes in the plate head and Universal Locking System (ULS) holes in the shaft, which are figure- shaped and will accommodate standard or locking screws on either side of the hole. Locking Screw Technology The heads of the locking screws contain male threads while the holes in the plates contain female threads. This allows the screw head to be threaded into the plate hole, locking the screw into the plate. This technical innovation provides the ability to create a fixedangle construct while using familiar plating techniques. Locking Plate Technology By using locking screws in a bone plate, a fixed-angle construct is created. In osteopenic bone or fractures with multiple fragments, secure bone purchase with conventional screws may be compromised. The locking screws do not rely on bone/plate compression to resist patient load but function similarly to multiple small angled blade plates. In osteopenic bone or multifragmentary fractures, the ability to lock screws into a fixed-angle construct is imperative. With the addition of universal locking holes in the shaft, the plate can be used as both a locking device and a fracture compression device. If compression is desired, it must be achieved first by inserting the standard screws in the compression screw holes before inserting any locking screws. The locking plate design does not require compression between the plate and bone to accommodate loading. Therefore, purchase of the screws in the bone can be achieved with a thread profile that is shallower than that of traditional screws. The shallow thread profile, in turn, allows for screws with a large core diameter to accommodate loading with improved bending and shear strength.

5 Zimmer Periarticular Plates Surgical Technique Plate Features The tapered plate shaft design allows for a minimally invasive technique The plates are precontoured to help with metaphyseal/diaphyseal reduction The low profile plate facilitates fixation without impinging on soft tissue The plate shaft includes Universal Locking System (ULS) holes, which are figure- shaped and will accommodate standard or locking screws on either side of the hole. As a result, the plate can be used, depending upon the fracture situation, as a compression plate, a locked internal fixator or as an internal fixation system combining both techniques The Plates are available in seven (7) lengths, from hole (0mm) to 6 hole (6mm) The anatomical shape of the head of the plate matches the shape of the distal lateral fibula Locking holes in the plate head allow placement of the screws to capture fragments while avoiding lag screws that have been placed outside the plate The ULS holes enable the surgeon to: Treat fractures using compression plating techniques with standard cortical or cancellous screws Apply the implant as an internal fixator to bridge highly comminuted zones while providing stable fixation Utilize both standard and locking screws in the same construct Apply bi-directional axial compression within the construct Utilize unicortical locking fixation as necessary Indications The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Fractures in osteopenic bone Nonunions Malunions Fracture Classification The OTA classification for long bone fractures is divided into three general groups each with three subgroups. The groups are extra-articular, partial articular, and complex articular. The subgroups reflect the degree of metaphyseal comminution. Refer to the OTA Fracture and Dislocation Compendium for more specific information.

6 Zimmer Periarticular Plates Surgical Technique Fixation Principles Standard Plating Anatomic Reduction of the Fracture Fragments Rigid Fixation Preservation of the soft tissues and blood supply to the bone Early movement of the patient Screws tighten plate to bone to generate compression Screw threads in bone are under a load applied intraoperatively Patient loads (weight and movement) add to the amount of preload on the bone/plate/screw construct May assist with reduction and alignment during placement Plate relies on absolute stability for primary healing Locked Plating Anatomic reduction of the articular surface Stable fixation Careful handling and preservation of the soft tissues and blood supply to the bone Early movement of the patient Screws lock to plate Screws inserted into bone with minimal axial preload No stress in the system (bone or plate) prior to patient loads Plate is not compressed to bone reducing constriction of blood supply Does not reduce or align the fracture during its placement Plate acts as a splint relies on relative stability for secondary healing and callus formation A long plate and adequate spacing between the locking screws is required for use as a bridge-plate. The longer the plate the better. The main biomechanical and resulting clinical benefits of locked internal fixators are: The plate and screws form one stable system in which the stability of the fracture depends on the stiffness of the construct. Locking the screw into the plate ensures angular and axial stability, eliminating the possibility for screw toggling or loosening. This, in turn, reduces the risk of postoperative loss of fixation. Locking screws do not rely on plate/bone compression but function similarly to multiple small angled blade plates. In osteopenic bone, comminuted fractures, and other areas where traditional screw fixation may be compromised, the ability to lock screws into a fixed angle construct is imperative. Improved biology for healing bridging the fracture with a locked construct does not compress the periosteum or disrupt the fracture hematoma, thereby improving chances for fracture healing. Combined Plating utilizing two biomechanical principles interfragmentary compression and bridging techniques Note: If lag screw fixation is necessary for any fragment, the lag screw must be inserted before inserting locking screws into that fragment. Reduce the fracture Use lag screws to restore articular anatomy Use cortical or cancellous screws to draw the plate to the surface of the bone Insert locking screws - locking screws lock the plate to the bone regardless of whether or not the fragments are reduced Note: In comminuted fractures, it may not always be possible or desirable to achieve anatomic reduction of the fracture. Combined plating is used most effectively for: Articular fractures with comminuted fracture extension into the diaphysis Segmental fractures which include one simple fracture pattern and one comminuted fracture pattern

7 Zimmer Periarticular Plates Surgical Technique Surgical Technique Required Instrumentation The following sets may be required for application of the Distal Lateral Fibular Locking Plates: Basic Instrument Set Basic Forcep Set Periarticular Distal Lateral Fibular Locking Plate Set (includes instruments and implants) Preoperative Preparation After assessing the fracture radiographically and preparing a preoperative plan, place the patient in the lateral position on a radiolucent table. Be sure that the fluoroscope can be positioned to visualize the distal fibula in both the lateral and Anterior/ posterior (A/P) views. Fibular fractures may be isolated or they may occur with ankle fractures, pilon fractures, or tibial fractures. Fibular fixation is a necessary component of the initial surgical management of tibial fractures, because an accurate reestablishment of the proper fibular length and rotation indirectly reduces the tibia due to the strong ligamentous attachments. Secondly, this provides a lateral column that a medially based external fixator can be tensioned against to correct any persistent shortening and angulation of the tibia. Third, and most importantly, an accurate fibular reduction maximally reduces the posterolateral tibial articular segment through the posterior tibiofibular ligaments, greatly enhancing an open reduction. Surgical Approach The patient is positioned supine on a radiolucent operating table, if the fibula fracture occurs with an ankle, pilon, or tibia fracture. For an isolated fibula fracture the patient is placed in the lateral position on a radiolucent operating table. The surgical approach for fixation of the fibula should be in a posterolateral location, posterior to the palpable back border of the fibula. This allows for the use of this same incision, if a posterolateral approach is later chosen, and increases the soft tissue bridge, if an anterolateral exposure is required for tibial fixation. Additionally, the incision is centered off the subcutaneous fibula, helping to minimize wound complications in this location. This incision can be extended proximally and/ or distally as more exposure is required. Take care not to place incisions over the proposed sites of implants, or where there is risk of devitalizing sensitive structures. Fibular fixation is dependent on the location and the mode of failure. Transverse fractures at the joint line indicate a tension failure of the fibula. Conversely, comminuted or wedge fractures proximal to the joint line are typical of valgus overload compressive fractures. The importance of an accurate reduction of the fibula cannot be over emphasized. Indirect techniques to regain length may be necessary, especially in high energy pilon fractures with significant associated shortening and soft tissue swelling. Fracture Reduction It is imperative that accurate reduction of the fracture be obtained prior to and maintained during application of the distal lateral fibular locking plate. Reduce the intra-articular fragments using linear bone clamps or Kirschner wires to temporarily hold the reduction. Use lag screws to secure the intraarticular fragments. To help avoid inserting the lag screws where they will interfere with the plate placement, hold the plate on the bone in its approximate position. Then insert the lag screws as needed. Plate Positioning Hold the Jig on the plate (Fig. ). The Jig will help align the Cannulas so that they are threaded into the plate at the proper angle. Thread two.0mm Cannulas into holes in the distal portion of the plate through the Jig (Fig. ). Thread one additional.0mm Cannula into the most proximal plate hole. Fig.

8 Zimmer Periarticular Plates Surgical Technique When the first wire is satisfactory, adjust the plate position, if necessary. Then insert an additional.6mm or.0mm K-wire through the proximal Cannula to help prevent rotation of the plate (Fig. 5). If desired, after removal of the metaphyseal jig, additional K-wires can be inserted through the distal K-wire holes to further stabilize the plate. Fig. It is easier to thread the cannulas into the plate holes before the plate is applied to the bone. The cannulas can be used as handles to position the plate. Remove the Jig and place the plate on the bone (Fig. ). Check plate placement visually and fluoroscopically if necessary. Use anatomic landmarks and fluoroscopic images to position the plate. Because the fibular shaft may not be aligned with the distal fragment, the plate head should be used to determine the appropriate placement of the plate. The plate head should conform to the shape of the intact or reconstructed distal lateral fibula. This will determine the alignment of the shaft. Fig. Hold the plate in the desired position and insert a.6mm or.0mm K-wire through one of the Cannulas in the distal portion of the plate until the tip engages the opposite cortical wall (Fig. ). Use the fluoroscope to confirm the position of the wire in both the A/P and lateral planes. Adjust the wire location if necessary. If preferred, use a bone clamp or bone reduction instrument to secure the plate. Fig. 5 Use the fluoroscope for both A/P and lateral views to confirm the position of the plate head, shaft and guide wires. Fig.

9 Zimmer Periarticular Plates Surgical Technique Screw Selection The Periarticular Locking Distal Lateral Fibular Plate System includes the following screws:.5mm Periarticular Cortical Screws with.7mm Heads in lengths from 0mm to 70mm 00--XXX-5.7mm Cortical Screws, Self-tapping in lengths from 0mm to 6mm 00-7-XXX-0.0mm Cancellous Screws in lengths from 6mm to 5mm 00-0-XXX-00.7mm Conical Screws in lengths from 0mm to mm XXX-6.5mm Locking Screws with.7mm Heads in lengths from 0mm to mm XXX-.7mm Locking Screws in lengths from 0mm to mm 00--XXX-0 Fracture Fixation Metaphyseal Screw Fixation Note: If required, lag screw reduction of a fragment must be accomplished before inserting any locking screws. The.7mm Conical Screws can be used for lag screw fixation. WARNING: Contouring or bending the plate at a threaded hole may deform the threaded hole and cause incompatibility with the Locking Screw in that hole. Determine placement of the first.7mm Conical Screw in the Metaphysis (Fig. 6). This screw will be used to compress the plate to the bone. Insert the.0mm Calibrated Drill Bit through the.0mm Cannula and drill to the appropriate depth (Fig. 7). Read the screw length directly from the Drill Bit; or if desired, remove the Drill Bit and Cannula and insert the.7mm Locking Screw Standard Depth Gauge into the drill hole to measure for screw length (Fig. ). Fig. 7 Fig. 6 Fig.

10 Zimmer Periarticular Plates Surgical Technique Predrilling and tapping are typically not necessary as the flutes of the screws are self-tapping. If the bone is dense, the lateral cortex can be predrilled using the.7mm Drill Bit and, if necessary, tapped using the.5mm Standard Screw Tap for.5mm Locking Screws. Use the.0mm Drill Bit or the.7mm Standard Screw Tap for.7mm locking screws. Use the.5mm Hex QC Screwdriver Bit to insert a.7mm Conical Screw into the pre-drilled hole. To insert locking screws in the distal portion of the plate, thread a.0mm Cannula into the hole where a locking screw will be placed (Fig. 9). Insert the.0mm Calibrated Drill Bit through the.0mm Cannula and drill to the appropriate depth (Fig. 0). Read the screw length directly from the Drill Bit; or if desired, remove the Drill Bit and Cannula and insert the.7mm Locking Screw Standard Depth Gauge into the drill hole to measure for screw length (Fig. ). Follow the same procedure for each additional locking screw. Fig. 0 Fig. Fig. 9

11 Zimmer Periarticular Plates Surgical Technique A driver shaft can be used to loosely insert the locking screws under power, but the final seating must be accomplished by hand to avoid cross-threading of the screws in the plate holes or breakage of the screws or driver (Fig. ). Shaft Fixation If both locking and nonlocking screws will be used in the shaft, the nonlocking screws must be inserted first. Insert the first standard cortical or cancellous screws through one of the proximal ULS plate holes. Use the appropriate drill guide (.5mm/.5mm Double Drill Sleeve) in one of the ULS holes in the shaft (Fig. ). Use the.5mm Standard Drill to drill through both cortices (Fig. ). Use the Depth Gauge to measure the appropriate screw length (Fig. 5). Then insert a selftapping lag screw. Check the position of the screw with the fluoroscope. Repeat this procedure for each of the standard screws to be inserted. Fig. Fig. Note: If the plate shifts during screw insertion, all the pins and screws must be removed and reinserted for the screws to lock properly to the plate. Note: If a plate screw impinges on one of the intra-articular lag screws, the lag screw must be removed and repositioned. Fig. Fig. 5

12 0 Zimmer Periarticular Plates Surgical Technique To insert.7mm Locking Screws, thread the.0mm Standard Cannula into one of the ULS holes in the shaft of the plate. Use the.0mm Standard Drill through the cannula to drill a pilot hole (Fig. 6). Check the depth and position of the drill with fluoroscopic images. Remove the cannula and use the Depth Gauge to measure the appropriate screw length (Fig. 7). Then insert the locking screw (Fig. ). Fig. 6 Fig. 7 Fig. For.5mm Locking Screws use the.7mm Standard Cannula and the.7mm Drill Bit. A driver shaft can be used to loosely insert the locking screws under power, but the final seating must be accomplished by hand to avoid crossthreading of the screws in the plate holes or breakage of the screws or driver. Predrilling and tapping are typically not necessary as the flutes of the screws are self-tapping. If the bone is dense, the lateral cortex can be predrilled using the.0mm Drill Bit and, if necessary, tapped using the.7mm Standard Screw Tap for.7mm Locking Screws. Use the.7mm Drill Bit and.5mm Standard Screw Tap for the.5mm Locking Screws. Insert additional locking screws as desired. Wound Closure Use the appropriate method for surgical closure of the incision. Postoperative Treatment Postoperative treatment with locking plates does not differ from conventional open reduction internal fixation (ORIF) procedures. Please refer to the package insert for product information, including contraindications, warnings, and precautionary information. Surgical Pearls To achieve appropriate reduction and compression of the plate to the bone, follow the basic technique detailed below: PIN proximally PIN distally LAG proximally LAG distally LOCK proximally LOCK distally Load the Wire Driver into a Jacobs Chuck and load a Screwdriver Shaft into a Trinkle connector to prevent having to repeatedly connect and disconnect instruments from a single connector/ adapter. If the locking screw is difficult to insert or stops advancing before locking to the plate, remove the screw and pre-drill with the appropriate drill bit. Then reinsert the screw. (This condition may be caused by very dense or thick cortical bone.) Secure the PLATE to the BONE in at least two locations, one proximally and one distally using Cannulas and K-wires to maintain the position of the plate relative to the bone. DO NOT REMOVE these until fixation is stable and nearly complete. Removal of the proximal and distal cannulas will cause the plate to shift. Make sure that ALL LOCKING SCREWS ARE SECURELY TIGHTENED by hand before closing. A distractor or external fixator may also be useful in gaining reduction. Cleaning of the cannulated instruments is necessary for proper function.

13 Zimmer Periarticular Plates Surgical Technique Instruments and Implants Catalog No. Description Set Quantity Peri Dist Lat Fib Lock Plate Set Plate, Right, Hole, 0mm Plate, Right, 6 Hole, 06mm Plate, Right, Hole, mm Plate, Right, 0 Hole, 5mm Plate, Right, Hole, 0mm Plate, Right, 6 Hole, 06mm Plate, Right, Hole, mm Plate, Right, 0 Hole, 5mm Peri Dist Lat Fib Lock Inst Set Catalog No. Description Set Quantity mm Hex Standard Screwdriver, QC.7mm Locking Screw Standard Depth Gauge, Measures up to 90mm mm Standard Cannula mm ULS Screw Holding Sleeve mm Drill, QC, 00mm long mm Drill, QC, 0mm long mm Drill, QC, 00mm long mm Drill, QC, 0mm long mm/.0mm Double Drill Sleeve mm/.5mm Double Drill Sleeve Cleaning Stylet mm Tap, QC Cleaning Brush mm Standard Cannula (for.5mm locking screw with.7mm head) Torque Limiting Attachment Cannula Inserter Plate Jig, Right Plate Jig, Left mm Standard Tap, QC mm Standard Tap, QC mm Hex QC Standard Screwdriver Bit.0mm Standard Drill, QC, 75mm long.7mm Standard Drill, QC, 05mm long QC T Handle QC Handle mm Tap, QC Small Holding Sleeve Screw Holding Forceps mm ULS Compression Drill Guide Reduction Forceps, Ratchet, Serrated w/points, Narrow, mm length Reduction Forceps, Ratchet, Serrated w/points, Broad, mm length Reduction Forceps, Ratchet w/points, 05mm length Reduction Forceps, Ratchet, Serrated Jaws, 5mm length Self-centering Bone Forceps, Speed-Lock, 55mm length Hohmann Retractor, mm width, Short Narrow Tip, 65mm length Hohmann Retractor, 5mm width, 60mm length Periosteal Elevator, curved blade, round edge, 6mm blade width

14 Zimmer Periarticular Plates Surgical Technique Catalog No. Description Set Quantity Sharp Hook Catalog No. Description Set Quantity mm Conical Screw, 0mm Long Kwires,.5mm diameter, 50mm long, 0 per box box mm Conical Screw, mm Long Kwires,.6mm diameter, 50mm long, 0 per box box mm Conical Screw, mm Long Kwires,.0mm diameter, 50mm long, 0 per box box mm Conical Screw, 6mm Long Implant and Instrument Case mm Conical Screw, mm Long Peri Dist Lat Fib Lock Plate Screw Set mm Conical Screw, 0mm Long mm Head, 0mm Long mm Conical Screw, mm Long mm Head, mm Long mm Locking Screw with.7mm Head, 0mm Long mm Head, mm Long mm Locking Screw with.7mm Head, mm Long mm Head, 6mm Long mm Locking Screw with.7mm Head, mm Long mm Head, mm Long mm Locking Screw with.7mm Head, 6mm Long mm Head, 0mm Long mm Locking Screw with.7mm Head, mm Long mm Head, mm Long mm Locking Screw with.7mm Head, 0mm Long mm Head, mm Long mm Locking Screw with.7mm Head, mm Long mm Head, 6mm Long mm Cortical Self-tapping Screw, 0mm Long mm Head, mm Long mm Cortical Self-tapping Screw, mm Long mm Head, 0mm Long mm Cortical Self-tapping Screw, mm Long mm Head, 50mm Long mm Cortical Self-tapping Screw, 6mm Long mm Head, 56mm Long mm Cortical Self-tapping Screw, mm Long mm Head, 60mm Long mm Cortical Self-tapping Screw, 0mm Long mm Head, 65mm Long mm Cortical Self-tapping Screw, mm Long mm Head, 70mm Long mm Cortical Self-tapping Screw, mm Long mm Cortical Self-tapping Screw, 6mm Long

15 Zimmer Periarticular Plates Surgical Technique Catalog No. Description Set Quantity mm Cancellous Screws 6mm Long.0mm Cancellous Screws 0mm Long.0mm Cancellous Screws 5mm Long mm Locking Screw, 0mm Long mm Locking Screw, mm Long Catalog No. Description Set Quantity mm Head, 56mm Long.7mm Head, 60mm Long.7mm Head, 65mm Long.7mm Head, 70mm Long mm Conical Screw, 0mm Long mm Locking Screw, mm Long mm Conical Screw, mm Long mm Locking Screw, 6mm Long mm Conical Screw, mm Long mm Locking Screw, mm Long mm Conical Screw, 6mm Long mm Locking Screw, 0mm Long mm Conical Screw, mm Long mm Locking Screw, mm Long mm Conical Screw, 0mm Long Peri Dist Lat Fib Lock Plt Screw Set, Sterile mm Conical Screw, mm Long mm Head, 0mm Long mm Locking Screw with.7mm Head, 0mm Long mm Head, mm Long mm Locking Screw with.7mm Head, mm Long mm Head, mm Long mm Locking Screw with.7mm Head, mm Long mm Head, 6mm Long mm Locking Screw with.7mm Head, 6mm Long mm Head, mm Long mm Locking Screw with.7mm Head, mm Long mm Head, 0mm Long mm Locking Screw with.7mm Head, 0mm Long mm Head, mm Long mm Locking Screw with.7mm Head, mm Long mm Head, mm Long mm Cortical Self-tapping Screw, 0mm Long mm Head, 6mm Long mm Cortical Self-tapping Screw, mm Long mm Head, mm Long mm Cortical Self-tapping Screw, mm Long mm Head, 0mm Long mm Cortical Self-tapping Screw, 6mm Long mm Head, 50mm Long mm Cortical Self-tapping Screw, mm Long

16 Zimmer Periarticular Plates Surgical Technique Catalog No. Description Set Quantity mm Cortical Self-tapping Screw, 0mm Long.7mm Cortical Self-tapping Screw, mm Long.7mm Cortical Self-tapping Screw, mm Long.7mm Cortical Self-tapping Screw, 6mm Long.0mm Cancellous Screws 6mm Long.0mm Cancellous Screws 0mm Long.0mm Cancellous Screws 5mm Long mm Locking Screw, 0mm Long Catalog No. Also Available Description Sterile Only Plate, Right, Hole, mm, Sterile Plate, Right, Hole, 0mm, Sterile Plate, Right, 6 Hole, 6mm, Sterile Plate, Left, Hole, mm, Sterile Plate, Left, Hole, 0mm, Sterile Plate, Left, 6 Hole, 6mm, Sterile mm Locking Screw, mm Long mm Locking Screw, mm Long mm Locking Screw, 6mm Long mm Locking Screw, mm Long mm Locking Screw, 0mm Long mm Locking Screw, mm Long Peri Dist Lat Fib Lock Plate Set, Sterile Plate, Right, Hole, 0mm, Sterile Plate, Right, 6 Hole, 06mm, Sterile Plate, Right, Hole, mm, Sterile Plate, Right, 0 Hole, 5mm, Sterile Plate, Left, Hole, 0mm, Sterile Plate, Left, 6 Hole, 06mm, Sterile Plate, Left, Hole, mm, Sterile Plate, Left, 0 Hole, 5mm, Sterile

17

18

19

20 Please refer to package insert for complete product information, including contraindications, warnings, precautions, and adverse effects. Contact your Zimmer representative or visit us at +H977000/$070H07D ML Printed in USA 007 Zimmer, Inc.