REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/200
Report
- Report Number
- 0009613350-2018-01137
- Event Type
- Injury
- Date Received
- November 13, 2018
- Date of Event
- October 18, 2018
- Report Date
- March 6, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14; REF:01.00402-055 ; LOT:2861445. BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14; REF:00-8775-036-04 ; LOT:2872653. SHELL POROUS WITH CLUSTER HOLES 70 MM, REF: 00620207022, LOT: 61089668. LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D. F, REF: 00631007036, LOT: 62871789. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FRACTURE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A REVITAN SYSTEM ON (B)(6) 2017. THE REVITAN CONE BROKE AT THE TRANSITION TO THE NECK DUE TO WHICH THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018. REVIEW OF RECEIVED DATA: THE FOLLOWING X-RAY ANALYSIS WAS PERFORMED BY A HEALTH CARE PROFESSIONAL (HCP): RIGHT HIP JOINT WITH PROXIMAL FEMUR AP-VIEW (X-RAY 9), UNDATED BUT REPORTED AS (B)(6) 2017: DECENTERING FEMORAL HEAD, RADIOLUCENT LINE ON THE INTERFACE BETWEEN STEM COMPONENT AND CEMENT. NO EVIDENCE OF OSTEOLYSIS AROUND THE CUP. RIGHT HIP JOINT WITH PROXIMAL FEMUR AP-VIEW, UNDATED BUT REPORTED AS (B)(6) 2017 (X-RAY 3) AND (B)(6) 2017 (X-RAY 5): APPROXIMATELY EQUIVALENT PROJECTION OF THE STEM COMPONENT ON BOTH X-RAYS, PROJECTION-RELATED SMALL DIFFERENCE IN THE AREA OF THE CUP COMPONENT. CEMENT RESIDUALS LATERALLY IN THE PROXIMAL REGION OF THE DISTAL STEM COMPONENT. OSSEOUS FORM FIT IN THE AREA OF THE PROXIMAL STEM COMPONENT WITHOUT ANY INDICATION OF LOOSENING, NO INDICATION OF A MATERIAL FAILURE OF THE CONNECTION BETWEEN THE PROXIMAL AND DISTAL PART OF THE STEM. CLEARLY LOOSENED BONE STRUCTURE MEDIAL IN THE AREA OF THE CALCAR. RIGHT HIP JOINT WITH PROXIMAL FEMUR SECOND VIEW (X-RAY 4), UNDATED BUT REPORTED AS (B)(6) 2017: COMPARED TO THE AP-VIEW NO ADDITIONAL CONSPICUOUS FINDINGS. UNCHANGED CLEARLY LOOSENED BONE STRUCTURE MEDIAL ON CALCAR. RIGHT HIP JOINT WITH PROXIMAL FEMUR AP-VIEW (X-RAY 6 AND 7), UNDATED BUT REPORTED AS (B)(6) 2017 (X-RAY 6) AND (B)(6) 2017 (X-RAY 7): COMPARABLE TO THE TWO PREVIOUS X-RAYS 3 AND 5 NEW VISIBLE RADIOLUCENT AREA MEDIALLY OF THE PROXIMAL PART OF THE DISTAL COMPONENT. NO INDICATION OF A LOOSENING OF THE PROXIMAL COMPONENT. X-RAY 6 IS SLIGHTLY MORE EXTERNALLY ROTATED COMPARED TO X-RAY 7, THEREFORE, THE LESSER TROCHANTER IS MORE CLEARLY DISPLAYED. CLEARLY LOOSENED BONE STRUCTURE MEDIAL ON CALCAR. PELVIS OVERVIEW, LYING POSITION (X-RAY 8), UNDATED BUT REPORTED AS (B)(6) 2017: COMPARED TO THE TWO PREVIOUS X-RAYS 6 AND 7 NOTICEABLY INCREASED RADIOLUCENT LINE LATERALLY UP TO THE AREA OF THE PROXIMAL PART OF THE STEM WITHOUT INDICATION OF LOOSENING OR MATERIAL FAILURE. THE RADIOLUCENT LINE IS LIMITED BY A CLEARLY RECOGNIZABLE SCLEROSIS LINE MEDIAL AND LATERAL. COMPARED TO X-RAY 6 OSTEOLYTIC BONE STRUCTURE MEDIAL PROXIMAL IN THE AREA OF THE CALCAR. RIGHT HIP JOINT WITH PROXIMAL FEMUR AP-VIEW (X-RAY 1 AND 2), UNDATED BUT REPORTED AS (B)(6) 2017 FOR X-RAY 1 AND 2: THE PROXIMAL PART OF THE STEM IS SLIGHTLY TILTED MEDIALLY BY ABOUT 10°. THIS IS ALSO RECOGNIZABLE BY THE WIDENED GAP OF THE CONE CONNECTION ON THE LATERAL SIDE. UNCHANGED EXTENSIVELY LOOSENED BONE STRUCTURE MEDIAL IN THE AREA OF THE CALCAR. FOLLOW-UP QUESTIONS TO HCP: THE CHOICE OF A REVITAN IMPLANT FOR THE PATIENT SUBJECT OF THIS COMPLAINT? HCP: NO PRE-OPERATIVE RADIOLOGICAL ANALYSIS, AS DESCRIBED IN THE APPLICABLE SURGICAL TECHNIQUE IS AVAILABLE. THEREFORE, THE PRE-OPERATIVE STRATEGY OF THE SURGEON CANNOT BE FOLLOWED. THE CHOICE OF A PROXIMAL COMPONENT OF SIZE 55 MM IN COMBINATION WITH A 22/200 MM DISTAL COMPONENT? HCP: THE ONLY INFORMATION GIVEN BY THE SURGICAL REPORT IS THAT THE SURGEON SWITCHED TO A BIGGER SIZE AFTER INTRAOPERATIVE, RADIOLOGICAL CONTROL WITHOUT STATING ANY REASONS. ACCORDING TO THE SURGICAL REPORT THE INTRAOPERATIVE FIT OF THE ENDOPROSTHESIS IS RADIOLOGICALLY GIVEN. THE ONLY IMAGES THAT CAN GIVE INFORMATION ABOUT THE CHOICE OF IMPLANT SIZE AND POSITION ARE UNDATED X-RAYS. HOWEVER, SOLELY ONE X-RAY HAS ALSO A SECOND IMAGE PLANE. THEREFORE, THERE IS NO CONVENTIONAL-RADIOLOGICAL IMAGING GIVEN THAT WOULD ALLOW THE ASSESSMENT OF THE FEMORAL ANTETORSION. IMPLANT POSITIONING (ESPECIALLY OF THE PROXIMAL COMPONENT AND THE ANTETORSION)? ON THE X-RAYS 3 AND 5 THERE IS NO INDICATION OF A LACK OF PRIMARY STABILITY. FURTHER, THE PATIENT IS WITH A HEIGHT OF 195 CM RATHER TALL, WHICH MAY EXPLAIN THE CHOICE OF A 200 MM SHAFT LENGTH. REGARDING THE CORRELATION BETWEEN SHAFT SIZE AND LEG LENGTH, THERE IS ONLY ONE PELVIS OVERVIEW IN LYING POSITION GIVEN (X-RAY 8), WHICH SHOWS A SMALL LEG LENGTH REDUCTION, HOWEVER, THIS COULD BE A RESULT OF THE LYING AND THE SLIGHTLY TILTED PELVIS POSITION. THE SHAFT ANTETORSION CANNOT BE DETERMINED BASED ON THE GIVEN CONVENTIONAL-RADIOLOGICAL IMAGES. SURGICAL NOTES OF IMPLANTATION PERFORMED ON (B)(6) 2017: DATE OF SURGERY: (B)(6) 2017, SURGEON: CHIEF PHYSICIAN (B)(6) AUSTRUP, FACILITY: (B)(6). IMPLANTED DEVICES: REVITAN DISTAL CURVED UNCEMENTED 22/200. REVITAN PROXIMAL CYLINDRICAL UNCEMENTED 55. BIOLOX DELTA HEAD 36/+7. TRABECULAR METAL ACETABULR SYSTEM. TRILOGY LONGEVITY PE LINER. CLINICAL DIAGNOSIS: LOOSENING OF THE EXTERNALLY IMPLANTED TOTAL HIP ENDOPROSTHESIS ON THE RIGHT SIDE DUE TO FEMORAL NECK FRACTURE 12 YEARS AGO. SURGICAL DIAGNOSIS: SIGNIFICANT CUP LOOSENING WITH FOREIGN BODY GRANULATION RELATED LYSIS ZONES ALL AROUND THE CUP. ANAMNESIS: PREVIOUSLY DESCRIBED STEM AND CUP LOOSENING. PREOPERATIVE BACTERIOLOGICAL EXAMINATION WITHOUT PATHOLOGICAL FINDINGS, THEREFORE DECISION TO SURGICAL REVISION. DESCRIPTION OF PROCEDURE: TRANSGLUTEAL ACCESS AND OPENING OF THE JOINT. EXTENSIVE STEM LOOSENING WITH A LYSIS ZONE UNTIL BELOW THE CALCAR. AFTER EXTENSIVE DEBRIDEMENT OF GRANULATED TISSUE REMOVAL OF PROXIMAL CEMENT COMPONENTS. CONSEQUENTLY, REMOVAL OF DISTAL CEMENT COMPONENTS INLCUDING AN EARLIER IMPLANTED MEDULLARY PLUG. FOLLOWING, EXHIBITION OF THE CUP. REMOVAL OF EXTENSIVE PERIARTICULAR SCARRING. THE CUP IS RETRIEVED AFTER DORSAL AND CRANIAL CHISELLING AROUND THE MOBILE CUP. ON THE BOTTOM OF THE ACETABULAR CUP ARE EXTENSIVE RESORPTION- AND GRANULATION CYSTS. AFTER COMPLETE DEBRIDEMENT A CUP PERFORATION REMAINS AS A BONE DEFECT. ADDITIONALLY, REMAINING AREA OF RESORPTION TOWARDS THE ISCHIUM AND THE PUBIS AND CRANIALLY IN THE AREA OF THE ILEUM. REAMING OF THE ACETABULAR CUP UNTIL A FIRM SEAT OF THE REAMER WAS REACHED AT A DIAMETER OF 70 MM. REMAINING BONE DEFECTS ARE VERY SMALL, THEREFORE, NO INDICATION FOR A CORTICO-SPONGY TRANSPLANT AS PLACE HOLDER. FIRM SEAT OF THE IMPLANT. THE IMPLANT WAS INSERTED USING A STEEPER ANGLE TO OPTIMIZE THE BONY ANCHORAGE. USAGE OF A HIGH-WALL-INLAY 36 MM. REAMING AND RASPING OF THE FEMORAL CANAL UNTIL REVITAN SIZE 20/200. RADIOLOGICAL CONTROL SHOWS ALMOST PERFECT FIT. ENLARGEMENT OF THE CANAL FOR A SHAFT WITH AN OUTER DIAMETER OF 22 MM. THE STEM CAN BE IMPACTED, SO THAT A 55 MM PROXIMAL COMPONENT CAN BE USED. INSERTION OF A CERCLAGE WIRE AT THE HEIGHT OF THE CIRCULAR FIRM CORTICALIS WITH PERFECT FIT. MOUNTING OF THE NECK COMPONENT AND FIXATION USING THE TORQUE WRENCH. PROXIMAL CLOSURE. AFTER TRIAL REDUCTION USAGE OF A 36 MM XL HEAD WITHOUT DISLOCATION TENDENCY . POSTOPERATIVE TREATMENT: 6 WEEKS SOLE CONTACT, CONSEQUENTLY, 25 KG LOAD FOR ANOTHER 2 WEEKS, AFTER RADIOLOGICAL CONTROL POTENTIAL TRANSITION TO FULL LOAD. RADIOLOGICAL CONTROL AFTER 6 AND 8 WEEKS. SUMMARY: CEMENTED TOTAL HIP ENDOPROSTHESIS RECOGNIZABLE ON A RADIOGRAPH SHOWING THE RIGHT HIP WITH RADIOLOGICAL EVIDENCE OF STEM LOOSENING AND AN OUT OF CENTER FEMORAL HEAD AS AN INDICATION OF WEAR OF THE INLAY WITHIN LOADED AREA OF THE ACETABULUM. ON (B)(6) 2017 REVISION SURGERY OF THE RIGHT HIP ENDOPROSTHESIS WAS PERFORMED. BENEATH THE CUP BOTTOM RESORPTION AND GRANULATION CYSTS WERE FOUND. AFTER COMPLETE DEBRIDEMENT A PERFORATION OF THE BOTTOM OF THE ACETABULUM REMAINED AS A BONE DEFECT. A TANTALUM CUP OF SIZE 70 WAS INSERTED A LITTLE BIT STEEPER BUT WITH A FIRM SEAT IN COMBINATION WITH A HIGH-WALL INLAY. FIRST PREPARATION OF THE FEMORAL CANAL FOR A 22/200 MM REVITAN STEM WHICH RESULTED IN AN ALMOST PERFECT FIT. HOWEVER, CONSEQUENTLY PREPARATION OF THE FEMORAL CANAL FOR A 22/200 MM REVITAN STEM, WHICH WAS INSERTED AND SECURED WITH A CERCLAGE WIRE. INSERTION OF A 55 MM PROXIMAL REVITAN COMPONENT AND FIXATION USING THE TORQUE WRENCH. THE POSTOPERATIVE, RADIOLOGICAL CONTROL SHOWED A GOOD FIT OF THE ENDOPROSTHESIS WITHOUT INDICATION FOR FRACTURE. VARIOUS UNDATED X-RAYS WERE AVAILABLE FOR INVESTIGATION. CLEARLY VISIBLE IS AN INCREASING RADIOLUCENT LINE ON THE LATERAL SIDE OF THE REVITAN STEM (X-RAYS 3 AND 5). INITIALLY IN THE AREA OF THE PROXIMAL PART OF THE DISTAL REVITAN COMPONENT, SUBSEQUENTLY ALSO IN THE AREA OF THE PROXIMAL PART OF THE PROXIMAL REVITAN COMPONENT (X-RAY 8). RADIOLOGICALLY, AN INCREASINGLY LOOSENED BONE STRUCTURE IS SHOWN MEDIALLY AT THE LEVEL OF THE PROXIMAL REVITAN COMPONENT IN THE AREA OF THE CALCAR (X-RAY 8), ACCORDING TO THE INTRAOPERATIVELY DESCRIBED LYSIS ZONE BELOW THE CALCAR. ANAMNESTIC THE EVENT OCCURRED DURING A FOREST WALK. CONCLUSION: MEDICALLY, ON THE BASIS OF THE AVAILABLE INFORMATION, NO SPECIFIC ROOT CAUSE WAS IDENTIFIED WHICH COULD HAVE LED TO THE REPORTED REVISION SURGERY DUE TO A BREAKAGE OF THE CONE CONNECTION OF THE REVITAN STEM 21 MONTHS AFTER IMPLANTATION. THE LACK OF BONY SUPPORT ON THE MEDIAL SIDE OF THE PROXIMAL REVITAN COMPONENT IN THE AREA OF THE CALCAR, AS ALREADY DESCRIBED INTRAOPERATIVELY DURING THE PRIMARY SURGERY ON (B)(6) 2017 AND WHICH RADIOLOGICALLY INCREASED DURING THE TIME IN-VIVO, MAY HAVE CONTRIBUTED TO THE BREAKAGE OF THE CONE CONNECTION FROM A MEDICAL POINT OF VIEW. BFARM USER REPORT: SURGICAL TREATMENT OF A LOOSENED HIP TEP ON THE RIGHT SIDE ON (B)(6) 2017 CONDITION AFTER IMPLANTATION OF A THA AFTER FEMORAL NECK FRACTURE 12 YEARS AGO. POST-OPERATIVE NO COMPLICATIONS, AFTER SEVERAL WEEKS OF RELIEF PHASE OF THE PATIENT FINALLY BACK TO DAILY MOBILITY WITHOUT ANY PHYSICAL LIMITATIONS. ON (B)(6) 2018 DURING A WALK IN THE FOREST SUDDEN SYMPTOMS OF PAIN IN THE TREATED HIP JOINT ON THE RIGHT SIDE. CONSEQUENTLY, THE X-RAY DIAGNOSTICS SHOWED A FRACTURE OF THE CONNECTION BETWEEN THE REVITAN SHAFT AND THE 55 MM PROXIMAL REVITAN COMPONENT. ON (B)(6) 2018 DIFFICULT SURGICAL TREATMENT TO REVISE THE FRACTURED REVITAN SHAFT TO A CEMENTLESS WAGNER-REVISION SHAFT. DEVICES ANALYSIS: THE PRODUCT IS UNAVAILABLE FOR INVESTIGATION. ACCORDING TO THE AVAILABLE INFORMATION, THE PRODUCT WAS NOT RETURNED BY THE PATIENT. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED FROM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE : THE REVITAN HIP SYSTEM IS NOT DESIGNED FOR USE IN A FULLY UNSUPPORTED PROXIMAL FEMUR. BONE STOCK OF ADEQUATE QUALITY MUST BE PRESENT AND APPRAISED AT THE TIME OF SURGERY. FOR PATIENTS WITH SEVERE PROXIMAL DEFICIENCY, A SURGEON SHOULD CONSIDER SURGICAL OPTIONS TO ENSURE PROXIMAL BONE SUPPORT (SUCH AS MEDIAL AND/OR LATERAL STRUT GRAFTS) OR SWITCHING TO A MONOBLOCK REVISION STEM. ROOT CAUSE ANALYSIS. ROOT CAUSE DETERMINATION USING RMW: IMPLANT BREAKAGE, ASEPTIC LOOSENING OF STEM, STRESS SHIELDING, BONE STOCK CHANGES (E.G. HETEROTOPIC OSSIFICATION), OSTEOLYSIS DUE TO INCORRECT DISTRIBUTION OF LOAD DUE TO DESIGN = NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. ASEPTIC LOOSENING OF STEM, DISLOCATION, SUBLUXATION, BONE FRACTURE DUE TO INSUFFICIENT PRIMARY STABILITY DUE TO DESIGN = NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT . ASEPTIC LOOSENING OF STEM, STRESS SHIELDING, BONE STOCK CHANGES (E.G. HETEROTOPIC OSSIFICATION), OSTEOLYSIS, BONE FRACTURE DUE TO INSUFFICIENT SECONDARY STABILITY = POSSIBLE, AS THE X-RAY REVIEW SHOWED THAT THE RADIOLUCENCY INCREASED OVER THE TIME IN-VIVO. ABRASIVE WEAR, DISLOCATION, METALLOSIS, ASEPTIC LOOSENING OF STEM, IMPLANT BREAKAGE DUE TO DIFFERENT THERMAL EXPANSION OF COMPONENTS = NOT POSSIBLE, AS ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION THE MATERIAL HAS BEEN TESTED. FURTHER, A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. ABRASIVE WEAR, ASEPTIC LOOSENING OF STEM, ABRASIVE WEAR, METALLOSIS DUE TO MOVEMENT OF IMPLANT PART (PROXIMAL OR DISTAL) LEADS TO WEAR = POSSIBLE, AS THE DEVICES WERE NOT RECEIVED FOR INVESTIGATION AND SURGICAL NOTES OF THE REVISION ARE NOT AVAILABLE THIS CAUSE CANNOT BE EXCLUDED. ABRASIVE WEAR, DISLOCATION, METALLOSIS, ASEPTIC LOOSENING OF STEM DUE TO WRONG DESIGN OF PIN LEADING TO FAILURE OF CONNECTION BETWEEN PROXIMAL AND DISTAL PART AND SUBSEQUENT RELEASE OF WEAR PARTICLES (E.G. FRETTING) = NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, METALOSIS, DISLOCATION, ASEPTIC LOOSENING OF COMPONENTS DUE TO EXCESSIVE WEAR DUE TO MICROMOTION IN TAPER CONNECTION BETWEEN PROXIMAL STEM AND HEAD (E.G FRETTING) = POSSIBLE, AS THE DEVICES WERE NOT RECEIVED FOR INVESTIGATION AND SURGICAL NOTES OF THE REVISION ARE NOT AVAILABLE THIS CAUSE CANNOT BE EXCLUDED. IMPLANT BREAKAGE DUE TO INSUFFICIENT FATIGUE STRENGTH = NOT POSSIBLE, AS ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION THE MATERIAL HAS BEEN TESTED. FURTHER, A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. IMPLANT BREAKAGE DUE TO NOTCHING DUE TO LASER MARKINGS ON STEMS IN HIGH STRESSED AREAS = NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. IMPLANT BREAKAGE, STEM NECK FRACTURE, ASEPTIC LOOSENING OF COMPONENTS, DISLOCATION, SUBLUXATION, ABRASIVE WEAR, METALLOSIS, OSTEOLYSIS DUE TO IMPINGEMENT = POSSIBLE, AS AN IMPINGEMENT CANNOT BE EXCLUDED BASED ON THE GIVEN INFORMATION. IMPLANT BREAKAGE DUE TO MICROMOTION BETWEEN DISTAL STEM AND PIN LEADING TO PIN FRACTURE (E.G. FRETTING) = POSSIBLE, AS INDICATION FOR A FRACTURE OF THE DISTAL REVITAN COMPONENT WAS IDENTIFIED DURING INVESTIGATION. IMPLANT BREAKAGE DUE TO STEM WALL THICKNESS AROUND MODULAR CONNECTION (CONNECTION PIN) IS TOO SMALL = NOT POSSIBLE, AS THE DHR INDICATES THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. IMPLANT BREAKAGE DUE TO DESIGN SPECIFICATION NOT MET = NOT POSSIBLE, AS THE DHR INDICATES THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. IMPLANT BREAKAGE DUE TO DESIGN SPECIFICATION NOT MET = NOT POSSIBLE, AS THE DHR INDICATES THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. IMPLANT BREAKAGE, BONE FRACTURE DUE TO WRONG PLANNING TEMPLATE USED / MISINTERPRETATION OF THE X-RAY TEMPLATES REGARDING CENTER OF ROTATION/LEG LENGTH/OFFSET = POSSIBLE, AS NO PRE-OPERATIVE PLANNING WAS PROVIDED FOR INVESTIGATION THIS CAUSE CANNOT BE EXCLUDED. ASEPTIC LOOSENING OF STEM DUE TO INCOMPLETE REMOVAL OF CEMENT RESIDUE = POSSIBLE, AS THE X-RAY ANALYSIS REVEALED CEMENT RESIDUES ON THE LATERALLY OF THE PROXIMAL PART OF THE DISTAL REVITAN COMPONENT. IMPLANT BREAKAGE DUE TO INCORRECT RASPING/REAMING DIRECTION = POSSIBLE, AS INSUFFICIENT INFORMATION AND IMAGES ARE AVAILABLE THIS CAUSE CANNOT BE EXCLUDED. IMPLANT BREAKAGE/ DISLOCATION DUE TO USE WRONG TRIALS FOR TRIAL REDUCTION/ ANTETORSION OF PROXIMAL PART NOT ASSESSED = POSSIBLE, AS NO INFORMATION ABOUT TRIAL REDUCTION IS GIVEN IN THE SURGICAL REPORT OF THE PRIMARY IMPLANTATION. IMPLANT BREAKAGE OR IN-SITU BONE FRACTURE DUE TO WRONG IMPLANT SIZE SELECTED = NOT POSSIBLE, AS THE SURGICAL REPORT STATES A GOOD FIT OF THE PROSTHESIS AND NO LACK OF PRIMARY STABILITY WAS IDENTIFED BASED ON THE GIVEN X-RAYS. INADEQUATE RESTORATION OF JOINT KINEMATICS (E.G. CENTER OF ROTATION, LEG LENGTH DISCREPANCY) DUE TO WRONG IMPLANT SIZE SELECTED => NOT POSSIBLE, AS THE SURGICAL REPORT STATES A GOOD FIT OF THE PROSTHESIS AND NO LACK OF PRIMARY STABILITY WAS IDENTIFED BASED ON THE GIVEN X-RAYS. IMPLANT BREAKAGE/ DISLOCATION DUE TO WRONG POSITION OF DISTAL FEMORAL COMPONENT/ WRONG ANTETORSION FOR PROXIMAL PART CHOSEN = POSSIBLE, AS THE ANTETORSION COULD NOT BE DETERMINED BASED ON THE PROVIDED IMAGES. IMPLANT BREAKAGE DUE TO USAGE OF A WET AND/OR UNCLEAN CONNECTING TAPER = POSSIBLE, AS THE DEVICES WERE NOT RETURNED FOR INVESTIGATION THIS CAUSE CANNOT BE EXCLUDED. IMPLANT BREAKAGE DUE TO PROXIMAL AND DISTAL COMPONENT NOT FIRMLY TIGHTENED = POSSIBLE, AS THE DEVICES WERE NOT RETURNED FOR INVESTIGATION THIS CAUSE CANNOT BE EXCLUDED. IMPLANT BREAKAGE DUE TO EXCESSIVE IMPACTION LOAD/ TORQUE APPLIED TO STEMS WHILE ASSEMBLING LEADING TO DAMAGE OF MATERIAL = POSSIBLE, AS THIS CAUSE CANNOT BE EXCLUDED BASED ON THE GIVEN INFORMATION. IMPLANT BREAKAGE DUE TO USAGE OF A WET AND/OR UNCLEAN CONNECTING TAPER = POSSIBLE, AS THE DEVICES WERE NOT RETURNED FOR INVESTIGATION THIS CAUSE CANNOT BE EXCLUDED. IMPLANT BREAKAGE DUE TO PROXIMAL AND DISTAL COMPONENT NOT FIRMLY TIGHTENED = POSSIBLE, AS THE DEVICES WERE NOT RETURNED FOR INVESTIGATION THIS CAUSE CANNOT BE EXCLUDED. IMPLANT BREAKAGE DUE TO EXCESSIVE IMPACTION LOAD/ TORQUE APPLIED TO STEMS DURING ASSEMBLING LEADING TO DAMAGE OF MATERIAL = POSSIBLE, AS THIS CAUSE CANNOT BE EXCLUDED BASED ON THE GIVEN INFORMATION. IMPLANT BREAKAGE/ DISLOCATION DUE TO WRONG POSITION OF ASSEMBLED FEMORAL COMPONENT/ WRONG ANTETORSION FOR PROXIMAL PART CHOSEN = POSSIBLE, AS THE ANTETORSION COULD NOT BE DETERMINED BASED ON THE PROVIDED IMAGES. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN STEM AND HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO OFF LABEL USE/ WRONG COMBINATION OF COMPONENTS USED/COMBINATION WITH COMPETITOR PRODUCTS = NOT POSSIBLE, AS THE REPORTED PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN STEM AND HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO LASER MARKING NOT READABLE IN NORMAL LIGHTING CONDITIONS USE OF WRONG STEM COMPONENTS = NOT POSSIBLE, AS REDUCED READABILITY OF LASER MARKING WAS NOT REPORTED. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN STEM AND HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT = NOT POSSIBLE, AS NO ISSUE REGARDING INAPPROPRIATE INFORMATION WAS IDENTIFIED DURING INVESTIGATION. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN STEM AND HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO INSUFFICIENT DESCRIPTION OF SURGICAL PROCESS LEADS TO INTRAOPERATIVE ERRORS OR MISUSE OF IMPLANT OUTSIDE OF ITS SCOPE (E.G. SELECTION OF HEAVY PATIENTS AND/ OR INSUFFICIENT PROXIMAL BONE SUPPORT) = NOT POSSIBLE, AS NO ISSUE REGARDING INAPPROPRIATE INFORMATION OF SURGICAL PROCESS WAS IDENTIFIED DURING INVESTIGATION. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN STEM AND HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO SURGEON UNFAMILIAR WITH IMPLANTATION TECHNIQUE OF THIS STEM DESIGN (EARLY STABILITY, INCORRECT USE ETC.) = POSSIBLE, AS ACCORDING TO THE SURGICAL TECHNIQUE THE USAGE OF THE SMALLEST PROXIMAL REVITAN COMPONENT OF SIZE 55 MM SHOULD BE AVOIDED. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN CUP AND INSERT, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO INSUFFICIENT WARNING OF SIDE EFFECT/ CONTRA-INDICATIONS = POSSIBLE, AS THIS CAUSE CANNOT BE EXCLUDED BASED ON THE GIVEN INFORMATION. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN CUP AND INSERT, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO INAPPROPRIATE ADVICE BY SURGEON TO INFORM PATIENT ON ACTIVITIES AND LIMITS. = POSSIBLE, AS NO INFORMATION ABOUT THE ADHERENCE OF THE PATIENT TO THE REHABILITATION PROTOCOL IS GIVEN. IMPLANT BREAKAGE, ASEPTIC LOOSENING, FAILURE OF CONNECTION BETWEEN CUP AND INSERT, ABRASIVE WEAR, DISLOCATION, SUBLUXATION DUE TO UNKNOWN COMPATIBILITY LIST = NOT POSSIBLE, AS THE REPORTED PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: THE PATIENT WAS IMPLANTED WITH A REVITAN REVISION SYSTEM ON (B)(6) 2017 DUE TO A LOOSENED HIP TEP ON THE RIGHT SIDE CONDITION AFTER IMPLANTATION OF THE TEP DUE TO FEMORAL NECK FRACTURE 12 YEARS AGO. POSTOPERATIVE NO COMPLICATIONS, AFTER SEVERAL WEEKS OF RELIEF PHASE OF THE PATIENT FINALLY BACK TO DAILY MOBILITY WITHOUT ANY PHYSICAL LIMITATIONS. ON (B)(6) 2018 THE DISTAL REVITAN COMPONENT BROKE DURING A WALK IN THE FOREST DUE TO WHICH THE PATIENT UNDERWENT A DIFFICULT REVISION SURGERY ON (B)(6) 2018. AS MENTIONED IN THE SURGICAL NOTES OF THE PRIMARY IMPLANTATION, THERE WAS EXTENSIVE STEM LOOSENING OF THE PREVIOUSLY IMPLANTED STEM WITH A LYSIS ZONE UNTIL BELOW THE CALCAR. FURTHER, EXTENSIVE DEBRIDEMENT OF GRANULATED TISSUE AND CEMENT COMPONENTS HAD TO BE PERFORMED IN ADDITION. FOLLOWING A REVITAN SYSTEM 22/200 WAS IMPLANTED, IN ORDER TO MATE IT WITH A 55 MM PROXIMAL REVITAN COMPONENT. IT REMAINS UNKNOWN DUE TO WHICH REASONS A 55 MM PROXIMAL REVITAN COMPONENT WAS CHOSEN AND WHY THE REVITAN SYSTEM 22/200 WAS CHOSEN OVER THE REVITAN SYSTEM 20/200, AS IT WAS REPORTED THAT THE REVITAN SYSTEM 20/200 REACHED AN ALMOST PERFECT FIT. NEVERTHELESS, POSTOPERATIVE OSSEOUS FIT IN THE AREA OF THE PROXIMAL STEM COMPONENT WITHOUT ANY INDICATION OF LOOSENING, NO INDICATION OF A MATERIAL FAILURE OF THE CONNECTION BETWEEN THE PROXIMAL AND DISTAL PART OF THE STEM WAS FOUND, BUT, CLEARLY LOOSENED BONE STRUCTURE MEDIAL IN THE AREA OF THE CALCAR. RADIOLOGICALLY, INCREASING RADIOLUCENCY FIRST MEDIALLY THAN ALSO LATERALLY OVER THE TIME IN-VIVO. FINALLY, BASED ON X-RAY 2 A TILTING OF THE PROXIMAL REVITAN COMPONENT BY ABOUT 10° IS VISIBLE WHICH INDICATES AN IMPLANT FRACTURE AT THE TRANSITION FROM THE PROXIMAL TO THE DISTAL REVITAN COMPONENT. ACCORDING TO THE APPLICABLE SURGICAL TECHNIQUE THE REVITAN HIP SYSTEM SUBJECT TO THIS COMPLAINT IS NOT DESIGNED FOR USE IN A FULLY UNSUPPORTED PROXIMAL FEMUR. BONE STOCK OF ADEQUATE QUALITY MUST BE PRESENT AND APPRAISED AT THE TIME OF SURGERY. THEREFORE, IT IS POSSIBLE THAT THE REMAINING BONE STUCK AND/OR BONE QUALITY WAS INSUFFICIENT TO PROVIDE THE NECESSARY SUPPORT FOR THE REVITAN IMPLANT SYSTEM. FURTHER, ADDITIONAL PATIENT-RELATED FACTORS SUCH AS AGE, WEIGHT (BMI: 29), ACTIVITY LEVEL AND ADHERENCE TO REHABILITATION PROTOCOLS MAY HAVE NEGATIVELY INFLUENCED THE PERFORMANCE OF THE DEVICE. FURTHER, NEITHER THE REVISION REPORT, THE RETRIEVALS NOR PICTURES OF THE RETRIEVALS WERE RECEIVED, THEREFORE, THE CONDITION OF THE DEVICES IS UNKNOWN. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. HOWEVER, AS THE DEVICES WERE NOT RETURNED FOR INVESTIGATION A DETAILED ANALYSIS COULD NOT BE PERFORMED. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. IF THE RETRIEVALS OR ADDITIONAL INFORMATION BECOME AVAILABLE THIS CASE WILL BE RE-ASSESSED. CORRECTIVE AND/OR PREVENTIVE ACTIONS HAVE BEEN INITIATED TO PREVENT REOCCURRENCE OF POTENTIAL PIN BREAKAGES OF THE REVITAN REVISION HIP SYSTEM IN THE FUTURE. ZIMMER GMBH DECIDED TO INITIATE A FIELD ACTION IN ORDER TO PROACTIVELY INFORM THE SURGEONS ABOUT HIGH RISK PATIENTS AS THEY MIGHT NOT BE AWARE OF THE EXPLICIT WARNING IN THE IFU. THE ACTION WAS INITIATED ON JANUARY 13TH 2017. AS THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, THE USA/FDA IS NOT AFFECTED FROM THIS NOTIFICATION. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
NO EVENT UPDATE.
CONCOMITANT MEDICAL DEVICES: SHELL POROUS WITH CLUSTER HOLES 70 MM, CATALOG NO# 00620207022, LOT NO# 61089668; LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 70 MM O.D. SHELL, CATALOG NO# 00631007036, LOT NO# 62871789. THERAPY DATE : (B)(6) 2018. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907455 | REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/200 | REVITAN DISTAL PART | KWA | ZIMMER GMBH | N/A | 2746170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |