DUROM ACETABULAR COMPONENT 52/46 CODE L
Report
- Report Number
- 0009613350-2017-00585
- Event Type
- Injury
- Date Received
- April 28, 2017
- Date of Event
- March 30, 2017
- Report Date
- April 28, 2017
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: TREND HAS BEEN IDENTIFIED AND CAPA WAS INITIATED AND PERFORMED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A METASUL DUROM COMPONENT FOR ACETABULUM, UNCEMENTED, 52 46, CODE L ON THE LEFT SIDE ON (B)(6), 2005. THE PATIENT WAS REVISED ON (B)(6), 2017 DUE TO ARMD. THE DOCUMENT RECEIVED FILLED OUT BY THE SURGEON/COMPLAINANT STATES THAT THE DUROM SYSTEM WAS IMPLANTED WITH A CLS STEM (REF NO. 01.00295.009) WHICH WAS NOT REVISED. AS PRIMARY DIAGNOSIS, ARTHROSIS COXAE IS STATED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE DUROM CUP SHOWS DAMAGE MOST LIKELY FROM THE REVISION SURGERY, E.G. NICKS, SCRATCHES, POLISHING OF THE POROUS COATING AS WELL AS DEFORMED AND BROKEN OFF EQUATORIAL FINS. ON THE ARTICULATION SIDE OF THE DUROM CUP NUMEROUS FINE SCRATCHES AND A PARTIAL BORDERLINE BETWEEN THE LOADED AND THE UNLOADED AREA IS VISIBLE TO THE NAKED EYE. WITHIN THE LOADED AREA THERE ARE MATT APPEARING ZONES AND A STRIPE WITH FINE PARALLEL SCRATCHES CLOSE TO THE RIM. CLOSER EXAMINATION OF THE SMALL STRIPE UNDER THE MACROSCOPE (LEICA MZ16 A, EQ-ID: WNT-03-RSR-540-151663) REVEALED MICROPITS FORMING SMALL ARROW-SHAPED FORMATIONS. ON THE ANCHORING SIDE REMAINS OF BONE ATTACHMENTS CAN BE OBSERVED. THE ARTICULATION SURFACE OF THE METASUL® LDH HEAD SHOWS SEVERAL SLIGHT SCRATCHES AND A CLEAR BORDERLINE BETWEEN THE LOADED AND THE UNLOADED AREA IS VISIBLE TO THE NAKED EYE. ON ONE SIDE THE LOADED AREA REACHES SLIGHTLY BELOW THE HEAD¿S EQUATOR. WITHIN THE LOADED AREA THERE IS A STRIPE OF DENSE SCRATCHES AND SOME MATT APPEARING ZONES. THE HEAD¿S TAPER IS INCONSPICUOUS. THE ARTICULATION SURFACE WAS INSPECTED UNDER THE MICROSCOPE (NIKON EPIPHOT EQ-ID: WNT-03-RSR-540-151662) AT 200-TIMES MAGNIFICATION WITH DIFFERENTIAL INTERFERENCE CONTRAST (DIC). AS ALREADY VISIBLE TO THE NAKED EYE THE BORDERLINE BETWEEN LOADED AND UNLOADED AREA IS WELL RECOGNIZABLE. WHILE THE UNLOADED AREA AT THE BORDERLINE SHOWS SCRATCHES THE LOADED AREA APPEARS TO BE SMOOTH. THE STRIPE OF DENSE SCRATCHES IN THE LOADED AREA APPEARS TO BE THE MAIN LOADED ZONE EXHIBITING SCRATCHES MAINLY IN THE SAME DIRECTION HAVING DIFFERENT INTENSITIES. THE MATT APPEARING ZONES IN THE LOADED AREA REVEALED MICROPITS. THERE ARE PARTS OF THE LOADED ZONE THAT APPEAR LIKE AN UNLOADED ZONE WHERE SLIGHTLY PROTRUDING CARBIDES ARE RECOGNIZABLE. THE UNLOADED AREA SHOWS SCRATCHES IN DIFFERENT DIRECTIONS HAVING DIFFERENT INTENSITIES. IN THIS AS-RECEIVED STATE THE METASUL® LDH HEAD ADAPTER WAS STILL ASSEMBLED WITH THE METASUL® LDH HEAD AND WAS DISASSEMBLED USING THE EXTRACTOR DURING THE CLEANING PROCEDURE TO FURTHER EVALUATE THE HEAD ADAPTER. THERE IS NOTHING TO REPORT ABOUT THE OUTER SURFACE OF THE HEAD ADAPTER. ON THE INNER SURFACE OF THE HEAD ADAPTER SURFACE CHANGES DUE TO FRETTING CORROSION WERE FOUND. ADDITIONALLY, TWO MARKS CAN BE OBSERVED IN THE PROXIMAL REGION OF THE CONTACT AREA. WEAR MEASUREMENT: THE WEAR MEASUREMENTS OF THE ARTICULATION SURFACES OF THE METASUL® LDH HEAD AND THE DUROM CUP WERE CARRIED OUT ON A 3D MEASURING MACHINE TYPE CMM5, SIP GENEVA. ON THE WEAR MAP OF THE HEAD CREATED OUT OF THE MEASUREMENT DATA A CLEAR WEAR ZONE COULD BE IDENTIFIED WHICH CORRELATES WITH THE POSITION OF THE LOADED ZONE OBSERVED ON THE HEAD¿S ARTICULATION SURFACE. THE TOTAL, LINEAR WEAR VALUE IS 63.9M WHICH RESULTS IN A YEARLY WEAR RATE OF 5.4M. THE WEAR MAP FOR THE CUP INDICATES RIM LOADING WITH A MEASURED TOTAL LINEAR WEAR VALUE OF APPROXIMATELY 21.3M RESULTING IN A YEARLY WEAR RATE OF APPROXIMATELY 1.8M. DUE TO THE POSITION OF THE LOADED ZONES IT HAS TO BE ASSUMED THAT THE WEAR AREA COULD NOT BE MEASURED ENTIRELY, BECAUSE THE MEASUREMENT ONLY COVERS THE SURFACE FROM THE CENTER OF THE COMPONENT UP TO 80° FOR THE CUP AND UP TO 90° (EQUATOR) FOR THE HEAD. THEREFORE, THE ABOVE GIVEN WEAR VALUE FOR THE CUP DOES NOT REFLECT THE TRUE AMOUNT OF WEAR. FOR A METASUL-PAIRING WITH DIAMETER 28 OR 32 MM RETRIEVED WITHIN THE FIRST YEAR AN AVERAGE WEAR OF 27.8M / YEAR PER PAIRING WAS FOUND. RETRIEVALS EXPLANTED AFTER TWO AND MORE YEARS IN-VIVO HAD AN AVERAGE WEAR RATE OF 6.2M / YEAR PER PAIRING [1]. ACCORDING TO THE AVAILABLE INFORMATION THE DUROM PROSTHESIS WAS REVISED AFTER APPROXIMATELY 11 YEARS AND 11 MONTHS IN VIVO DUE TO ARMD. THE LATTER IS A GENERIC TERM WHICH SUMMARIZES THE HISTOPATHOLOGY SEEN IN ASSOCIATION WITH MOM HIP ARTHROPLASTIES INCLUDING ALVAL, LYMPHOID NEOGENESIS, GRANULOMATOUS INFLAMMATION AND METALLOSIS [2]. BASED ON THE AVAILABLE INFORMATION, THE EXISTENCE, TYPE AND EXTEND OF THE ALLEGED ARMD IN THIS CASE CANNOT BE VERIFIED. CLEAR OR AT LEAST PARTIAL BORDERLINES BETWEEN THE LOADED AND UNLOADED AREAS WERE OBSERVED ON THE DUROM CUP AS WELL AS ON THE METASUL LDH HEAD. THE DUROM CUP REVEALED MICROPITS FORMING SMALL ARROW-SHAPED FORMATIONS CLOSE TO THE RIM AS WELL AS MATT APPEARING ZONES. THE METASUL LDH HEAD SHOWED MICROPITS WITHIN THE LOADED AREA WHICH BOTH CAN BE ATTRIBUTED TO SURFACE FATIGUE. THE POSITION OF THE BORDERLINES AND THE SMALL ARROW-SHAPED FORMATIONS SEEN ON THE CUP POINT TO RIM LOADING. THE LATTER IS INFLUENCED BY THE POSITION OF THE IMPLANTS MOSTLY CUP INCLINATION AND ANTEVERSION. HOWEVER, AS NO X-RAYS WERE AVAILABLE AND BASED ON THE AVAILABLE INFORMATION IT WAS NOT POSSIBLE TO FURTHER EVALUATE THE REASON FOR THE RIM LOADING. THE WEAR MEASUREMENT FOR THE METASUL PAIRING ALSO INDICATE RIM LOADING FOR THE CUP. THE MEASURED WEAR VALUES FOR THE METASUL PAIRING CAN BE CONSIDERED IN THE SAME RANGE AS PREVIOUSLY REPORTED VALUES. HOWEVER, DUE TO THE POSITION OF THE LOADED ZONES THEY COULD PROBABLY NOT MEASURED ENTIRELY AND THE MAJOR PART OF THE WEAR DERIVES FROM THE HEAD. ON THE INNER SURFACE OF THE HEAD ADAPTER SURFACE CHANGES DUE TO FRETTING CORROSION WERE FOUND. BASED ON THE AVAILABLE DATA THE REASON FOR THESE SURFACE CHANGES CANNOT BE DETERMINED. BASED ON THE RETRIEVAL INVESTIGATION AND THE INFORMATION AT HAND IT CAN ONLY BE ASSUMED THAT THE ARMD CAN POSSIBLY BE ATTRIBUTED TO THE PHENOMENA SEEN ON THE INNER SURFACE OF THE HEAD ADAPTER AND THE WEAR RESULTING FROM THE RIM LOADING. HOWEVER, IT STAYS UNKNOWN TO WHICH EXTENT EACH OF THE OBSERVED PHENOMENA CONTRIBUTED TO THE REPORTED REASON FOR REVISION. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE USA, ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MANUFACTURER'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE USA WAS INITIATED IN NOVEMBER 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE USA. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 AS NOTIFICATION Z-2415/2426-2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). [1] RIEKER CB, SCHOEN R, KOETTIG P, SHEN M, KREVOLIN J, 2006, IN-VITRO VERSUS IN-VIVO ANALYSIS OF METAL-ON-METAL ARTICULATIONS, ABSTRACT 7892 OF THE 5TH WORLD CONGRESS OF BIOMECHANICS, JUL 29-AUG 4, MUNICH, GERMANY, JOURNAL OF BIOMECHANICS 2006; VOL. 39 SUPPL. 1, P. 120 [2] SCENIHR (SCIENTIFIC COMMITTEE ON EMERGING AND NEWLY IDENTIFIED HEALTH RISKS), THE SAFETY OF METAL-ON-METAL JOINT REPLACEMENTS WITH A PARTICULAR FOCUS ON HIP IMPLANTS, 24-25 SEPTEMBER 2014, ISBN 978-92-79-30135-3.
ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 15, 2017. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE USA, ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MANUFACTURER'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE USA WAS INITIATED IN NOVEMBER 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE USA. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 AS NOTIFICATION Z-2415/2426-2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. (B)(4).
IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 52/46 CODE L ON THE LEFT SIDE.
A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 52/46 CODE L ON AN UNKNOWN SIDE ON (B)(6) 2005. THE PATIENT WAS REVISED ON (B)(6) 2017 DUE TO ARMD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311828 | DUROM ACETABULAR COMPONENT 52/46 CODE L | DUROM ACETABULAR COMPONENT AND METASUL LDH | KWA | ZIMMER GMBH | N/A | 2246348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R |