Merete BioBall The Innovative Hip Endoprosthesis Head Adapter System

Transcription

1 Merete the «BioBall Company» You are better off with BioBall Your Indispensable Assistant in Hip Arthroplasties. Merete BioBall The Innovative Hip Endoprosthesis Head Adapter System

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3 BioBall System Merete BioBall The Innovative Modular Hip Endoprosthesis Head Adapter System The modular BioBall adapter system consists of standard and offset adapter components, which are combined as desired with the following joint head components: BioBall delta Ceramic Head BioBall Metal Head BioBall Duo Head Bipolar BioBall Mono Head This unique concept offers the surgeon a high measure of intraoperative flexibility. Incorrect positions of the prosthesis stem and the hip socket can be compensated by the appropriate selection and positioning of the adapter. Any risk of dislocation after THR is minimized or even prevented entirely. In a large number of clinics this system already accompanies nearly all primary and revision surgeries. During surgery, standard neck length corrections from S (-3.0 mm) up to 5XL (+21 mm) can be carried out with the BioBall standard adapters. In addition, the offset adapters allow for neck length correction, a medialization or lateralization, as well as a correction of retro- or antetorsion. The adapters are available for prosthesis stems with standard tapers 12/14* and 14/16* (*stem tapers that meet the CeramTec BIOLOX specification) see page 14. Adapters for further hip stem tapers are available upon request. The adapters can only be combined with the BioBall heads. The adapters are designed to assure a very high component reliability with the maximum possible Range of Motion - ROM. Indications Socket revision at which the prosthesis stem remains in situ Revision of prosthesis bearings Intraoperative correction of neck length and/or offset Intraoperative correction of retro-/anteversion Compensation of the leg length difference in the context of soft tissue management Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 3

4 The 8 Guiding Thoughts of the BioBall System The 8 Guiding Thoughts of the BioBall System 01. Neck Length For patient-specific adaptation of the neck length and optimal physiological joint reconstruction, 8 adapter lengths from S to 5XL are available. This provides a high degree of intraoperative flexibility and reliability for the surgeon. 02. CCD Angle/Antetorsion The offset adapters allow a correction of the CCD [caput-collum-diaphysis] angle by 7.5 with respect to the neck axis of the prosthesis. Continuous rotary fine adjustment allows a correction of the ante- or retrotorsion. In this way the stem position of the head center is uncoupled and it gives the surgeon the possibility of implanting the prosthesis stem with an optimal soft tissue situation. In case of an already implanted prosthesis, a varus or valgus stem position can be compensated. The neck angle of the prosthesis can be precicely adapted to the position in the entry plane of the socket, resulting in the optimal extent of Range of Motion. 4

5 The 8 Guiding Thoughts of the BioBall System 03. Unique Feature for Revision Surgeries The manufacturers of ceramic components demand: In case of revision surgeries, if the existing stem remains, the use of a new ceramic head directly on the used hip stem taper is impermissible. However, according to the doctrine Once ceramic, always ceramic revisions require ceramic components again. Once ceramic, always ceramic As a result of fracture of ceramic components, ultrafine ceramic splinters occur. Because hardly any fracture particles can be removed during surgery, there is a great risk of third-body wear, leading to considerably reduced implant performance and early failure, particularly during the use of metal heads. Only by using a renewed ceramic/ceramic tribology third-body wear can be minimized, the implant performance can be exploited and long-lasting function can be guaranteed. The BioBall System offers in these situations a flexible, modular, rapid and safe solution. The Solution: The BioBall System! A new BioBall adapter is fixed to the already used taper of the stem which has been left in situ. The metal adapter compensates for slight deformities of the taper surface. For the ceramic ball a new taper with a perfect surface quality for reliable anchoring is now available. The adapters are in any case available with standard tapers of 12/14* and 14/16* (*Stem tapers that meet the CeramTec BIOLOX specifications and the test according to ISO ). Adapters for other stem tapers can be supplied on request. Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 5

6 The 8 Guiding Thoughts of the BioBall System 04. Individual Combination of Slide Bearings In case of a revision, independently of the primary implanted bearings, the change to other desired or required bearings is simplified. This allows the surgeon to use the best combination, individually adapted to the patient. The following system compatibilities are approved: Components of the BioBall adapter system are compatible with all the tapers that meet the CeramTec BIOLOX specification (taper 12/14 and 14/16 or other tapers see page 14). BioBall metal heads may be combined only with liners made of PE (UHMWPE [ultra-high molecular weight polyethylene]). BioBall BIOLOX delta* heads may only be combined with BIOLOX forte* or delta* liners or with PE (UHMWPE) liners or sockets. Cup BIOLOX delta* ceramic BIOLOX delta* ceramic BIOLOX forte* ceramic BIOLOX delta* ceramic UHMWPE UHMWPE Head BIOLOX delta* ceramic Metal Combination of Tribologies 05. Range of Motion The adapters are optimized for a maximum ROM. The values required for the ROM according to ISO are exceeded if even the smallest heads or the longest adapters are used. Larger head diameters increase the possible ROM. When using BioBall adapters, it is possible to switch to larger heads. In this way, the patient s mobility and freedom of movement improves where as the risk of dislocation is being minimized. *BIOLOX forte and BIOLOX delta are registered trademarks of the CeramTec AG. 6

7 The 8 Guiding Thoughts of the BioBall System 06. Highly Precise Surface Quality The surface quality of articulating surfaces has a substantial effect on abrasive behavior and is therefore a key factor for the life span of the implant. The smoothest surface improves lubrication and thus decreases wear. One value for the technical description of roughness is the arithmetic mean roughness, Ra, which can be calculated, for example, from the adjacent measurement. The Ra value of the BioBall metal heads, up to Ra = µm, is extremely low (ISO max. Ra = 0.05 µm) and even comparable to the values of ceramic heads. µm 0,15 0,1 0,05 0-0,05-0,1 0 0,1 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9mm 07. Mechanical Tests and Quality Assurance For the determination of the prosthesis neck strength when using BioBall adapters, fatigue tests have been carried out on Merete stems according to ISO standards. These tests passed the following standards without limitation. ISO / ISO ISO / ASTM F2068 The strength of BioBall adapters was also examined. Using the following standards, the strength was carried out by pressure loading on the ceramic heads until rupture occurred: ISO FDA ceramic head test: ASTM C IMA test specification: C/25 (accredited laboratory) In all cases, the rupture strength was above the required values. The BioBal l adapter system and the associated instruments are manufactured with the highest precision, and are subject to strict continuous quality verification. Additional successful examinations: Pull out tests according to ISO Fretting tests according to ASTM F Fatigue strength examination of the ceramic heads Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 7

8 The 8 Guiding Thoughts of the BioBall System 08. Methodically Designed Surgical Technique BioBall Adapter System Standard Careful removal of the existing head from the hip stem using the Selection of the appropriate trial adapter for the desired shortening or extension and attachment on the prosthesis head extractor with appropriate separating wedge (Figure 1). taper. Selection of the desired trial head with the desired diameter and attachment on the trial adapter (Figure 2). Location of the joint (Figure 3). Intraoperative verification of the range of movement to verify the neck length and ROM. After a successful test run, replacement of the trial components by the corresponding implants (Figures 4 and 5). Figure Abb. 1: 1: Use Demontage of the head des extractor alten Steckkopfes with an appropriate separating wedge 8

9 The 8 Guiding Thoughts of the BioBall System trial head trial adapter Figure 2: Mounting trial adapter system Figure 3: Trial system in reposition Figure 4: Attachment of the implant Figure 5: Implant in reposition Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 9

10 The 8 Guiding Thoughts of the BioBall System BioBall Adapter System Offset Careful removal of the existing head from the hip stem using the head extractor with appropriate separating wedge. Selection of the desired offset trial adapter (regarding the desired neck length correction/offset adjustment) and attachment on the prosthesis taper. To facilitate the orientation, the offset implant and the offset trial components are marked with a scale. Using a sterile marker pen, for example Merete SteriPen ( EP13402), apply a marking line at an easily accessible place on the prosthesis neck. The marking serves for the orientation during the directional positioning of the offset adapter (Figure 6). Alternatively, the orientation can be achieved using the arrow on the front surface of the trial adapter and the implant (Figure 7). Selection of the trial head with the desired diameter and attachment of the trial adapter. Location of the joint. Perform intraoperative test run to check neck length, offset and ROM. By turning the trial adapter counterclockwise, the CCD angle and retro- or antetorsion can be adjusted. When the desired position is reached, read the position of the trial adapter on the line marking and record. After a successful test run, the trial components are replaced by the corresponding implants. Attach the adapter in accordance to the defined marking onto the stem. Attach the head. line marking arrow marking displays the 12 o clock position trial implant Figure 6: Alignment of the trial adapter Figure 7: Additional orientation aid 10

11 The 8 Guiding Thoughts of the BioBall System Examples of Offset Adjustment Figures 8-10 show the possibilities of a change in position of the head epicenter by the offset adapter. positioning scale Figure 9: Medialization of the stem Figure 8: Lateralization of the stem ATTENTION! To find the correct offset position of the implant turn it counterclockwise and always refer to the numbers on the bottom of the implant according to the determined trial position (see Figure 8-10) 12 Figure 10: Antetorsion or retrotorsion Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 11

12 The 8 Guiding Thoughts of the BioBall System Simple Separation of the Components A fixed offset trial adapter can be detached from the prosthesis taper by using of the head extractor with the appropriate separating wedge and the universal handle (Figure 11). Abb. 11: Use of the head extractor with an appropriate separating wedge Separation of the Adapter and the Head In the case where the BioBall head has to be separated from the BioBall adapter, the adapter extractor should be used as follows: Loosen by unscrewing the clamp handle up to the ring marking (Figure 12). Push the BioBall adapter with the head over the separating sheath until the adapter engages behind the lip (Figure 13). Turn the clamp handle clockwise until the head is detached from the adapter (Figure 14). Turn the clamp handle counterclockwise until the ring marking becomes visible again. The BioBall adapter can be removed from the adapter extractor. ring marking Figure 12: Use of the adapter extractor lip Figure 13: Representation of the lip Figure 14: Pushing off the heads 12

13 The 8 Guiding Thoughts of the BioBall System Separation of the Adapter and the Head (Adapter 12/14 S or Adapter 14/16 M) Please note: If a BioBall Adapter 12/14 of size S or a BioBall Adapter 14/16 of size M was used, the extractor sleeve must be attached to the adapter extractor in addition for separation of the BioBall head (Figure 15). Then the adapter extractor can be used as described in the step on page 13 (Figure 16). extractor sleeve Figure 15: Attachment of the extractor sleeve to the adapter extractor Figure 16: Use of the adapter extractor with extractor sleeve Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 13

14 Ordering Information BioBall Ordering Information BioBall BioBall Adapter-System WARNING! BioBall Adapters can only be combined with BioBall heads. Standard 12/14 BioBall Adapter-System Standard 12/14 sterile Neck Length S (-3.0) M (0) L (+3.5) XL (+7.0) 2XL (+10.5) 3XL (+14.0) 4XL (+17.5) 5XL (+21.0) HM30121 HM30122 HM30123 HM30124 HM30125 HM30126 HM30127 HM30128 Offset 12/14 BioBall Adapter-System Offset 12/14 sterile Neck Length M (0) L (+3.5) XL (+7.0) 2XL (+10.5) 3XL (+14.0) 4XL (+17.5) 5XL (+21.0) Offset (mm) HM30222 HM30223 HM30224 HM30225 HM30226 HM30227 HM30228 Standard 14/16 BioBall Adapter-System Standard 14/16 sterile Neck Length M (0) L (+3.5) XL (+7.0) 2XL (+10.5) 3XL (+14.0) 4XL (+17.5) 5XL (+21.0) HM30142 HM30143 HM30144 HM30145 HM30146 HM30147 HM30148 Offset 14/16 BioBall Adapter-System Offset 14/16 sterile Adapters for more taper specifications are available on request. Length 2XL (+10.5) 3XL (+14.0) 4XL (+17.5) 5XL (+21.0) Offset (mm) HM30445 HM30446 HM30447 HM30448 Material: Ti6Al4V 14

15 Ordering Information BioBall BioBall Modular Heads WARNING! BioBall heads can only be combined with BioBall Adapters. BioBall Metal Head ATTENTION! Not for use in combination with metal sockets (metal on metal resurfacing hip systems). BioBall delta Ceramic Head ATTENTION! Exclusively in connection with polyethylene sockets and inlays (UHMWPE), implant with BIOLOX forte* or BIOLOX delta* inlays from CeramTec AG! Material: Vivium *** Material: BIOLOX delta* ceramic sterile Ø sterile Ø sterile Ø sterile Ø HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm Additional BioBall Heads BioBall Duo Head Bipolar** sterile Ø HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm Material: Vivium ***, UHMWPE HM mm HM mm HM mm ATTENTION! Not for use in combination with metal sockets (metal on metal resurfacing hip systems). BioBall Mono Head sterile Ø HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm HM mm Material: Vivium *** HM mm HM mm HM mm ATTENTION! Not for use in combination with metal sockets (metal on metal resurfacing hip systems). * BIOLOX forte and BIOLOX delta are registered trademarks of CeramTec AG. ** External and internal head premounted, as an economic and safe solution, sterile packaging! *** Vivium (High Nitrogen Stainless Steel - ISO ) is a registered trademark of Merete Medical GmbH. Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 15

16 Ordering Information BioBall BioBall Trial Adapters Length Standard 12/14 Offset 12/14 Standard 14/16 Offset 14/16 S (-3,0) HM M (0) HM40122 HM40222 HM L (+3,5) HM40123 HM40223 HM XL (+7,0) HM40124 HM40224 HM XL (+10,5) HM40125 HM40225 HM40145 HM XL (+14,0) HM40126 HM40226 HM40146 HM XL (+17,5) HM40127 HM40227 HM40147 HM XL (+21,0) HM40128 HM40228 HM40148 HM40448 BioBall Trial Heads Ø Ø Ø HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM HM

17 Ordering Information BioBall BioBall Instruments Handle for Duo and Mono Trial Heads HM10006 Adapter Extractor HM20001 Extractor Sleeve for Adapter 12/14 S HM20002 Extractor Sleeve for Adapter 14/16 M HM20003 Size Separating Wedge Universal Handle HM10007 S HM10005 HM10008 M HM10009 L Head Impactor HM10004 Type OP Planning: X-Ray Templates HMRS001 12/14 Standard Symmetric HMRS005 12/14 Offset HMRS002 14/16 Standard Symmetric HMRS006 14/16 Offset Technical changes reserved. Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 17

18 Ordering Information BioBall BioBall Sterilizing Trays* BioBall Sterilizing Tray Standard for 12/14-14/16 tapers (fully equipped) HM30600 BioBall Sterilizing Tray Duo/Mono Standard 12/14 tapers (fully equipped) HM50500 * Trays for other tapers on request. 18

19 Other Merete Products MultiCup Locking PressFit Cup MultiCup Locking PressFit Cup The First Cementless PressFit Cup with Locking Screws The threads in the cup and the screw threads have the same pitch. The locking principle increases the total stability of the implant preventing migration and tilting of the screws. The modular structure offers the surgeon a high measure of intraoperative flexibility. The cups are available in 9 sizes, the inlays in polyethylene (PE) as standard or highwall version as well as in BIOLOX forte/delta ceramics. During revisions the system enables an optional fixation with locking screws in 5 different positions. The porous titanium plasma coating of the MultiCup ensures the primary fixation of the implant due to a rough profile with high depth as well as best secondary long-term stability due to bone ingrowth. Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax +49 (0) service@merete.de 19

20 Merete Medical GmbH Alt-Lankwitz Berlin Germany Phone: +49 (0) Fax: +49 (0) ENBB All rights reserved Cover: Laurent Berthelot Fotolia.de