Ease of Use. Have the instrument you need when you need it.

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Dwayne Bruce
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Removes both cemented and non cemented hip stems Designed to extract both simple & difficult to remove hip stems Offers full range of attachment options Ability to clamp onto the trunnion directly

2 Removes both cemented and non cemented hip stems Designed to extract both simple & difficult to remove hip stems Offers full range of attachment options Ability to clamp onto the trunnion directly Ability to attach to predrilled - tapped hole available on some stems Ability to drill & tap new attachment hole on stems Ease of Use Provides method to enable surgeon to cut trunnion from top of stem. Allows sufficient force to be applied parallel to canal, reducing chances of splitting the femur. Have the instrument you need when you need it. Contact Information: Tel:+1 (888)-4shukla ( ) customer.service@shuklamedical.com

3 Hip Stem Extraction System No. Part Number Description QTY Case, Hip Stem Extraction System Lid, Hip Stem Extraction System Stem Extractor Femoral Head Puller Hip Extraction Hook Monoblock Hip Stem Extractor Tray, Hip Stem Extraction System #12-24 UNC-2A Male Extractor #12-28 UNC-2A Male Extractor ¼-20 UNC-2A Male Extractor ¼-28 UNF-2A Male Extractor /16-18 UNC-2A Male Extractor /16-24 UNF-2A Male Extractor /8-16 UNC-2A Male Extractor /8-24 UNF-2A Male Extractor /16-14 UNC-2A Male Extractor /16-20 UNF-2A Male Extractor M5 x 0.8-6G Male Extractor M5 x 0.9-6G Male Extractor M6 x G Male Extractor M6 x 1.0-6G Male Extractor M7 x 1.0-6G Male Extractor M8 x 1.0-6G Male Extractor M8 x G Male Extractor M10 x 1.0-6G Male Extractor M10 x G Male Extractor 2 SHUKLA MEDICAL 151 OLD NEW BRUNSWICK ROAD, PISCATAWAY, NJ BR-0XXX Rev A

104-00 Hip Stem Extraction System No. Part Number Description QTY 104-30 M10 x 1.

4 Hip Stem Extraction System No. Part Number Description QTY M10 x 1.5-6G Male Extractor 2 28 MMI1222 T-Handle, Hudson 1 29 SH700 Shaft Driver, Thread-F ¼-28 hudson 1 30 MIWW ½ & 11/16 Double Open End Wrench 1 31 WR140 9/32 & 11/16 Double Open End Wrench 1 32 MMM5 5lb. Mallet 1 33 MIWN 7/16-20 UNF-2B Nut, Hex 3 34 MIWE Extraction Frame 1

5 SURGICAL TECHNIQUE Simplifying Hip Stem Extraction The Xtract-All Hip Stem Extraction System has been designed in consultation with Dr. Wael Barsoum, M.D and Dr. Viktor Krebs, M.D

6 1 Xtract-Hip: Hip Stem Extraction System Intended Use The Xtract-All HIP Stem Extraction System has been designed for removal of well fixed hip stem prostheses during hip revision surgeries. The system consists of a variety of instrumentation geared towards removal of varying designs of hip stems including but not limited to modular, tapered neck, Monoblock, threaded, etc. Indications for Use For use by, or as directed by, a surgeon in hip revision surgeries. For use when the extraction of hip implants using instrumentation and techniques described in this operative technique guide have been determined to be appropriate by the surgeon. Contraindications The Xtract-All Hip Stem Extraction System consists of multiple attachment methods specific to a variety of hip stem implants being revised. All attachment configurations ultimately connect to the C-frame assembly and require repeated blows of a mallet to extract the implanted hip implant. Hence, when insufficient quality, quantity of bone or conditions that might result in fracture of the femur during extraction exist, the provided instrumentation should not be used to extract the implant (s). Warnings and Precautions Preoperative The surgeon should be familiar with general principles of revision surgery and techniques for removal of implants. The instruments should be inspected for visible damage prior to use. Do not use the product if damage is suspected. Only validated cleaning & sterilization procedures should be used Operative Due to the excessive bone ingrowth on fully porous coated straight and bowed stems, it is not recommended to use this system for removal of such implants. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to use. Proper handling and storage of the instrumentation is mandatory. Damage to the instrumentation may produce stresses and cause defects, which could become a focal point for failure. The surgeon should be cautious with limb position change and/or excessive force exertion while extracting implants using the instrumentation provided in the tray. FCD-0358 Rev 01

Xtract-Hip: Hip Stem Extraction System 2 System Features Instrumentation for easy and quick removal of femoral head.

Instrument attached via a camlock ensuring a connection that doesn't slip off the implant neck during extraction.

Instrumentation for removal of stems with cross holes or cross slots. C-frame plus mallet extraction method offers greater surgeon control and extraction force.

7 Xtract-Hip: Hip Stem Extraction System 2 System Features Instrumentation for easy and quick removal of femoral head. 20 different threaded extractor sizes for removal of stems with threaded proximal insertion holes. Single streamlined instrument for clamping and locking onto hip stem trunnion. Instrument attached via a camlock ensuring a connection that doesn't slip off the implant neck during extraction. Clamping onto taper stems achieved via a locking mechanism outside body thus allowing attachment through much smaller incisions. Instrumentation for extraction of monoblock hip stems. Instrumentation for removal of stems with cross holes or cross slots. C-frame plus mallet extraction method offers greater surgeon control and extraction force. All instrumentation contained within a single sterilization and storage case, thus eliminating the need to open multiple sets during surgery. 1Determine stem type For the best possible surgical outcome of the Xtract-Hip system, it is necessary to preoperatively check for one of three stem types, i.e. proximal threaded stems, modular stems or mono block stems. Removal instrumentation is available for each of the aforementioned stem types; choose the extraction method based on the type of stem identified. Tapered Neck Stem Monoblock Stem Proximally Threaded Stem FCD-0358 Rev 01

Utilize the femoral head disassembly instrument (104-05) to detach the head from the hip implant neck. 3. Slide the femoral head disassembly instrument into the hip implant neck as shown (Figure A).

8 3 Xtract-Hip: Hip Stem Extraction System 2Tapered Neck Stem Removal A. Femoral Head Disassembly 1. Removal of the femoral head is essential before proceeding with extraction of the tapered neck hip stems. 2. Utilize the femoral head disassembly instrument (104-05) to detach the head from the hip implant neck. 3. Slide the femoral head disassembly instrument into the hip implant neck as shown (Figure A). 4. For greater offset necks and/or longer heads adjust the sleeve spacing by rotating the adjustment nut. 5. Adjust sleeve spacing until the inner sleeve rests against the femoral head and outer sleeve against the femoral neck. 6. Once the sleeve spacing has been adjusted, press down on the instrument handle as shown (Figure B) to detach the femoral head from neck. 7. The femoral head is retained inside the inner sleeve for easy disposal. FIGURE A FIGURE B Note: The femoral head disassembly instrument can be used on femoral heads up to 56mm in outer diameter. FCD-0358 Rev 01

4 Xtract-Hip: Hip Stem Extraction System 3Threaded Stem Removal 1. Threaded implants are stems that have a threaded hole slightly lateral to the femoral neck on the proximal surface of the stem. 2.

Select appropriate thread size from 20 different available options. 4. Attach extractor shaft (SH700) to quick connect T-Handle (MMI1222). 5.

9 4 Xtract-Hip: Hip Stem Extraction System 3Threaded Stem Removal 1. Threaded implants are stems that have a threaded hole slightly lateral to the femoral neck on the proximal surface of the stem. 2. In case of modular systems, if removal of femoral head is desired prior to stem removal, first begin with technique outlined in Step # 2 of this operative guide. 3. Select appropriate thread size from 20 different available options. 4. Attach extractor shaft (SH700) to quick connect T-Handle (MMI1222). 5. Thread selected extractor to extractor shaft (SH700) and tighten with wrench (WR140). 6. Using quick disconnect T-Handle thread shaft into the proximal end of the stem (Figure C). FIGURE C 7. Once complete, attach C-frame (MIWE) and proceed to extract implant with repeat blows of the mallet (MMM5) onto the strike plate of C-frame (Figure D). FIGURE D FCD-0358 Rev 01

5 Xtract-Hip: Hip Stem Extraction System B. Clamp on tapered neck 1. Once the femoral head has been detached from the neck, proceed with extraction of the femoral stem. 2.

10 5 Xtract-Hip: Hip Stem Extraction System B. Clamp on tapered neck 1. Once the femoral head has been detached from the neck, proceed with extraction of the femoral stem. 2. Select the Hip Stem Extraction Instrument (104-04) from the tray. 3. Adjust the distal jaw opening of the instrument by rotating the proximal handle either in clockwise (to close) or counter clockwise (to open) direction. 4. After adjusting the jaw to desired opening, slide over the neck of the implant. 5. Rotate the proximal handle in clockwise direction thus closing the jaw over the femoral neck. 6. Once the jaw begins to experience resistance, it indicates that the instrument has begun to clamp onto the neck. 7. Prior to locking the instrument onto the neck a final check must be made to ensure the axis of the instrument is in-line with the hip stem. If not, manually make adjustment before pressing down on handle. 8. At this point stop rotating any further and press down on the handle till it reaches the locked position. Pressing down onto the handle ensures a firm grasp and locks the instrument onto the neck/trunnion of the hip implant. 9. Once complete, attach C-frame (MIWE) and proceed to extract implant with repeat blows of the mallet (MMM5) onto the strike plate of C-frame. FCD-0358 Rev 01

This scenario becomes particularly challenging in the absence of proximal threaded holes, which could be used to aid in the extraction of the stem. 2.

11 6 Xtract-Hip: Hip Stem Extraction System 4Monoblock Stems 1. Extraction of Monoblock stems is difficult since the femoral head is integral with the neck and cannot be detached prior to extraction of the stem. This scenario becomes particularly challenging in the absence of proximal threaded holes, which could be used to aid in the extraction of the stem. 2. When encountered with a Monoblock stem without proximal holes, the Monoblock Stem extractor (104-07) should be used (Figure E). 3. Thread the extractor onto extractor shaft (SH700). 4. Once complete, attach C-frame (MIWE) and proceed to extract implant with repeat blows of the mallet (MMM5) onto the strike plate of C-frame. FIGURE E 5Slotted or Cross Hole Stems FIGURE F 1. For an additional method of extracting stems, the Xtract-All Hip Stem Extraction set includes a hook style extractor (104-06). 2. This extractor can be used to removal hip stems that have through holes and/or slots (Figure F). 3. Thread the extractor onto extractor shaft (SH700). 4. Once complete, attach C-frame (MIWE) and proceed to extract implant with repeat blows of the mallet (MMM5) onto the strike plate of C-frame. FCD-0358 Rev 01

12 7 Xtract-Hip: Hip Stem Extraction System Order Information Part No. Description Qty Part No. Description Qty Hip Stem Extraction Set Case, Hip Stem Extraction Set Lid, Hip Stem Extraction Set Tray, Hip stem Extraction Set #12-24 UNC-2A Extractor #12-28 UNC-2A Extractor ¼-20 UNC-2A Extractor ¼-28 UNF-2A Extractor /16-18 UNC-2A Extractor /16-24 UNF-2A Extractor /8-16-UNC-2A Extractor /8-24-UNF-2A Extractor /16-14 UNC-2A Extractor /16-20 UNF-2A Extractor M5 X 0.8-6g Extractor M5.5 X 0.9-6g Extractor M6 X g Extractor M6 X 1.0-6g Extractor M7 X 1.0-6g Extractor M8 X 1.0-6g Extractor M8 X g Extractor M10 X 1.0-6g Extractor M10 X g Extractor M10 X 1.5-6g Extractor 2 MMI1222 T-Handle, Hudson 1 SH700 Shaft Driver w/ Hudson Extractor Assembly, Hip Stem Disassembly Instrument, Femoral Head Hook Extractor Monoblock Stem Extractor 1 MIWW Wrench, 1/2 & 11/16 Double Open End WR140 Wrench, 5/16 & 1/2 Double Open End MMM5 Mallet 1 MIWN 7/16-20 UNF-2B Nut, Hex 3 MIWE Extraction C-Frame 1 Cleaning and Sterilization For detailed sterilization instructions, kindly refer to industry standards ANSI/AAMI ST79:2012 & A1:2012 and ANSI/AAMI ST8:2001. Note: All Shukla Medical surgical instruments require manual cleaning with a neutral Ph cleanser. Open and disassemble all instruments, making sure to remove all contamination prior to sterilization. Machine washing is not recommended and maintenance and care using an autoclaveable lubricant on movable parts is required to preserve the life of the instrument. For more cleaning, inspection, maintenance and care tips contact Shukla Medical directly Contact a Shukla Medical representative or visit us at SHUKLA MEDICAL 151 Old New Brunswick Road Piscataway New Jersey U.S.A PHONE: 1 (888)-4SHUKLA FAX: +1 (732) FCD-0358 Rev 01

Surgical Technique Guide

Surgical Technique Guide FCD: 0423 REV: 03 Introduction The Xtract-All Knee System is a universal extraction system intended to remove knee implant hardware manufactured by a wide range of orthopedic companies.