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Patient 1
THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR INVESTIGATION. SURGICAL NOTES OF IMPLANTATION AND LABELS OF PRODUCTS IMPLANTED WERE RECEIVED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORD WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL REPORT WILL BE SUBMITTED. NOTE: THIS IS A SPLIT COMPLAINT WITH ZIMMER INC. (B)(4) AND WAS REPORTED UNDER B)(4) (0001822565 - 2016 - 03223). THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E. METASUL HEAD 36, 12/14, SIZE M/0 REF# (B)(4)) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. ZIMMER?S REFERENCE NUMBER OF THIS FILE IS (B)(4).
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Patient 1
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN METASUL, HEAD, M, 32/0, TAPER 12/14 ON RIGHT SIDE ON (B)(6) 2006. THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO DISLOCATION, BONE DEGENERATION AND MOM
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Patient 1
TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT, BMI=(B)(6), HAD AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006. THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO DISLOCATION, BONE DEGENERATION AND MOM. REVIEW OF RECEIVED DATA - PRIMARY IMPLANTATION DATED (B)(6) 2006: PRE-OP DIAGNOSIS: RIGHT HIP OSTEOARTHRITIS. OPERATION: POSTEROLATERAL EXPOSURE USING UNCEMENTED COMPONENTS PERFORMED. WHEN THE STEM SIZE 7 HAD BEEN IN PLACE IT WAS REALIZED THAT THE SOFT TISSUE TENSION WAS VERY LOOSE. THEREFORE ITS DECIDED TO GO WITH STEM SIZE 8 IN ORDER TO HAVE SOME SOFT TISSUE TENSION. THE OPERATED LEG, WHICH WAS A BIT SHORTER THAN THE NON-OPERATED LEG, BECAME LONGER BY HALF A CENTIMETER. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING DFMEA: - MICRO MOTION, FRETTING CORROSION, DECREASE OF TAPER CONNECTION STRENGTH DUE TO PARTICLES BETWEEN STEM TAPER AND BALL HEAD => POSSIBLE: PARTICLES LEFT BETWEEN HEAD/LINER CAN LEAD TO WEAR, HOWEVER IT CANNOT BE CONFIRMED, THEREFORE THIS RISK CANNOT BE EXCLUDED. - INCREASED RELEASE OF WEAR PARTICLES DUE TO 3RD BODY WEAR DUE TO PARTICLES (BONE CEMENT, CERAMIC PARTICLES FROM FORMER REVISION) => NOT POSSIBLE: NO CEMENTED THA APPLIED. - INCREASED RELEASE OF WEAR PARTICLES, LOOSENING OF COMPONENTS, FOREIGN BODY REACTION DUE TO INCREASED WEAR FROM ARTICULATION DUE TO INSUFFICIENT WEAR PERFORMANCE OF COMPONENTS (MATERIAL, SURFACE, CLEARANCE) => NOT POSSIBLE: COMPATIBILITY SPECIFICATION CERTIFIES THE WEAR PERFORMANCE. - INCREASED RELEASE OF WEAR PARTICLES, LOOSENING OF COMPONENTS, SUBLUXATION, DISLOCATION DUE TO IMPINGEMENT OF COMPONENTS DUE TO DESIGN => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. - INCREASED RELEASE OF WEAR PARTICLES, DISFUNCTION OF JOINT DUE TO DISLOCATION, SUBLUXATION => POSSIBLE: NO X-RAYS WERE RECEIVED TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. - INADEQUATE ROM (IMPINGEMENT) LEADING TO INCREASED RELEASE OF WEAR PARTICLES, LOOSENING OF COMPONENTS, SUBLUXATION, DISLOCATION DUE TO WRONG CUP POSITION, IMPINGEMENT OF THE SKIRTED HEAD WITH ACETABULAR LINER => POSSIBLE: NO X-RAYS WERE RECEIVED FOR INVESTIGATION TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. - INCREASED WEAR DUE TO MICRO SEPARATION => POSSIBLE: THE PRODUCTS WERE NOT RECEIVED FOR INVESTIGATION, THEREFORE CANNOT BE EXCLUDED. - LOOSENING OF HEAD/STEM TAPER CONNECTIONS DUE TO INAPPROPRIATE TAPER CONNECTION DESIGN => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. - INSTABLE TAPER CONNECTION DUE TO DIFFERENT TEMPERATURE COEFFICIENT OF DIFFERENT MATERIALS (ASSEMBLY VS. IN VIVO) => NOT POSSIBLE: TEMPERATURE COEFFICIENT BETWEEN DIFFERENT METAL ALLOY ARE NEGLIGIBLE. - METAL ION RELEASE - INCREASED SERUM COBALT AND SERUM CHROMIUM DUE TO WEAR AND METAL ION RELEASE => POSSIBLE: THE PRODUCTS WERE NOT RECEIVED FOR INVESTIGATION, THEREFORE CANNOT BE EXCLUDED. - INCREASED WEAR, LOSS OF TAPER CONNECTION, DISLOCATION DUE TO HIGH PATIENT ACTIVITY => POSSIBLE: PATIENT ACTIVITY LEVEL IS NOT KNOWN. - MAL-FUNCTION OF ARTICULATION, LEADING TO EXCESSIVE WEAR DUE TO WRONG MATERIAL COMBINATIONS => NOT POSSIBLE: MATERIAL COMBINATION IS APPROVED BY ZIMMER BIOMET. - MAL-FUNCTION OF ARTICULATION, LEADING TO EXCESSIVE WEAR DUE TO OFF LABEL USE, COMBINATION WITH COMPETITOR PRODUCTS => NOT POSSIBLE MATERIAL COMBINATION IS APPROVED BY ZIMMER BIOMET. - INCREASE PARTICLE AND METAL ION RELEASE, INCREASED WEAR, LOSS OF TAPER CONNECTION, SUBLUXATION, DISLOCATION DUE TO INCREASED ANTE/RETRO-VERSION OF THE STEM MAY INCREASE JOINT LOADING => POSSIBLE: NO X-RAYS WERE RECEIVED FOR INVESTIGATION TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. - DISLOCATION, INCREASED MICRO SEPARATION DUE TO SOFT TISSUE LAXITY => POSSIBLE: SOFT TISSUE LAXITY OF THE PATIENT WAS INDICATED IN THE IMPLANTATION REPORT. IT IS POSSIBLE THAT IT REACTIVATED SOME YEARS AFTER THE IMPLANTATION. - INCREASED RELEASE OF WEAR PARTICLES, LOOSENING OF COMPONENTS, SUBLUXATION, DISLOCATION DUE TO IMPINGEMENT OF COMPONENTS DUE TO MALPOSITION => POSSIBLE: NO X-RAYS WERE RECEIVED FOR INVESTIGATION TO CONFIRM, THEREFORE CANNOT BE EXCLUDED. - LOSS OF TAPER CONNECTION, WEAR DUE TO WRONG SIZING/COMBINATION (TAPER SIZING) => NOT POSSIBLE: MATERIAL COMBINATION IS APPROVED BY ZIMMER BIOMET. - INCREASED RELEASE OF WEAR PARTICLES DUE TO SCRATCHES ON ARTICULATION SURFACE FROM SURGEONS => POSSIBLE: IT CANNOT BE CONFIRMED IF IT HAPPENED OR NOT, THEREFORE CANNOT BE EXCLUDED. - INCREASED WEAR, FRETTING CORROSION (LEVER TORQUE) DUE T...