REVITAN DIST. CURVED 18/200
Report
- Report Number
- 0009613350-2018-01157
- Event Type
- Injury
- Date Received
- November 20, 2018
- Date of Event
- January 22, 2018
- Report Date
- September 7, 2020
- 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
- 003
Narratives
THIS FOLLOW UP REPORT HAS BEEN CREATE TO REFLECT THE ADDITIONAL INFORMATION WE RECEIVED. THE ADDITIONAL INFORMATION HAS BEEN REVIEWED AND THE INVESTIGATION OF THIS INCIDENT HAS BEEN RE-ASSESSED AND UPDATED. D11: - ITEM NUMBER: 01.00401.075; ITEM NAME: REVITAN PROX. SPOUT 75; LOT # 2603542. - ITEM NUMBER: 00-6200-064-20; ITEM NAME: TRILOGY FM ACET SHL 64 OD UNIV; LOT # 61878442. - ITEM NUMBER: 00-6250-065-25; ITEM NAME: TRILOGY BONE SCR 6.5X25; LOT # 62011529. .- ITEM NUMBER: 00-6250-065-25; ITEM NAME: TRILOGY BONE SCR 6.5X25; LOT # 62037915. - ITEM NUMBER: 00-6305-064-36; ITEM NAME: XLPE 0 DEG POLY LINER 64X36; LOT # 61817209. - ITEM NUMBER: 00-8775-036-02; ITEM NAME: BIOLOX DELTA HEAD 12/14 36X0; LOT # 2645296. - ITEM NUMBER: UNKNOWN; ITEM NAME: UNKNOWN SEPTOCOLL; LOT # UNKNOWN. EVENT DESCRIPTION: A PATIENT WAS IMPLANTED WITH A REVITAN REVISION SYSTEM ON THE RIGHT SIDE ON (B)(6) 2012. IN (B)(6) 2018 THE REVITAN PROSTHESIS FRACTURED DURING A WALK. THE REVISION TOOK PLACE ON THE 13TH OF (B)(6) 2018. DURING THE REVISION THERE WERE COMPLICATIONS TO RETRIEVE THE DISTAL REVITAN COMPONENT, DUE TO WHICH AN ARTHRONOMIE ON THE RIGHT KNEE JOINT WAS PERFORMED. FOLLOWING, DURING REMOVAL OF THE DISTAL PROSTHESIS A FRACTURE OF THE FEMUR OCCURRED. ANOTHER SURGERY TOOK PLACE ON THE 21ST OF (B)(6) 2018 TO TREAT THE FEMORAL BONE FRACTURE. REVIEW OF RECEIVED DATA: - LEGAL LETTER FROM KANZLEI HEYNEMANN, DATED (B)(6) 2018: FACTS OF THE CASE: - IMPLANTATION OF A REVITAN REVISION SYSTEM (ZIMMER PRODUCTS) ON THE RIGHT SIDE ON (B)(6) 2012 AFTER REMOVAL OF THE PREVIOUS PROSTHESIS DUE TO INFLAMMATION. THE REVITAN REVISION SYSTEM CONSISTS OF A REVITAN DISTAL CURVED, REF: 01.00406.218; REVITAN PROXIMAL SPOUT UNCEMENTED, REF: 01.00401.075. PRODUCT STICKERS ARE AVAILABLE. ON (B)(6) 2018 THE PROSTHESIS FRACTURED AT THE CONE WHILE NORMAL WALKING ON PLANE GROUND. ON (B)(6) 2018 REVISION SURGERY TOOK PLACE AT THE (ORTHOPÄDISCHES KRANKENHAUS SCHLOSS WERNECK). INTRAOPERATIVELY, IT WAS FOUND THAT THE REVITAN SHAFT WAS LOOSE AND FRACTURED EXACTLY AT THE CONE. FOLLOWING COMPLICATIONS OCCURRED. AN ARTHROTOMIE FOLLOWED AT THE RIGHT KNEE JOINT THEREBY THE DISTAL SHAFT PROSTHESIS WAS PUSHED UPWARDS AND A FEMUR FRACTURE OCCURRED DUE TO WHICH ANOTHER SURGERY TOOK PLACE ON (B)(6) 2018. DURING THE PERIOD OF (B)(6) 2018 THE PATIENT TOOK PLACE IN A REHABILITATION TREATMENT. HOWEVER, THE PATIENT WAS RELEASED BEING INCAPABLE OF WORKING. TILL (B)(6) 2018 THE PATIENT COULD ONLY MOVE WITH THE HELP OF FOREARM CRUTCHES. - LETTER FROM PROF. DR. MED. (B)(6) ((B)(6) ) ANSWERING FOLLOW UP QUESTIONS: 1. AT WHICH SITE DID THE IMPLANT FRACTURE? THE REVITAN REVISION SYSTEM FRACTURED AT THE SCREW CONNECTION/CONE BETWEEN THE PROXIMAL CONICAL COMPONENT AND THE DISTAL CURVED COMPONENT WITH AXIAL KINK FORMATION. 2. WERE ANY PIECES OF THE BROKEN DEVICE REMAINING IN THE PATIENT? NO IMPLANT PIECES REMAINED WITHIN THE PATIENT. 3. DID THE PATIENT HAVE COMPLICATIONS DURING SURGERY OR AFTER THE SURGERY? WHAT KIND OF COMPLICATIONS? THE PATIENT EXPERIENCED COMPLICATIONS DURING THE SURGERY CONSISTING OF A DISTAL FEMORAL NECK FRACTURE ON THE RIGHT SIDE FOLLOWED BY AN OPEN REPOSITION AND INSERTION OF AN ANGLE STABLE PLATE OSTEOSYNTHESIS WITH NCP PLATE AND PROXIMAL CERCLAGE WIRE ON (B)(6) 2018. 4. WHY WAS THERE AN ARTHROTOMIE IN THE RIGHT KNEE JOINT WHEN THE IMPLANTS ARE FOR THE HIPS? TO RETRIEVE THE DISTAL REVITAN COMPONENT. ARTHROTOMIE OF THE RIGHT KNEE JOINT WITH WINDOWING OF THE FEMORAL MEDULLARY CAVITY IN THE AREA OF THE NOTCH AND SUBSEQUENTLY PUSHING UP OF THE DISTAL SHAFT PROSTHESIS ON(B)(6) 2018. 5. HOW DID THE FRACTURE OF THE RIGHT FEMUR OCCUR AND WAS IT DEVICE RELATED? POSSIBLY THE FRACTURE OCCURRED DUE TO A PATIENT FALL ON CLEAR ICE IN (B)(6) 2018, AS, CONCERNING THE STATEMENT OF THE PATIENT, AT THIS TIME POINT THE MEDICAL CONDITIONS STARTED. PRIOR TO THAT THE PATIENT WAS FREE OF SYMPTOMS. THE FRACTURE OF THE DISTAL FEMUR OCCURRED MOST LIKELY INTRAOPERATIVELY THROUGH THE NECESSARY WINDOWING AND THE PUSHING OUT OF THE DISTAL REVITAN COMPONENT. 6. WHAT WAS IMPLANTED/EXPLANTED IN EACH SURGERY? SURGERY (B)(6) 2012: EXPLANTATIONS: - HIP SPACER. IMPLANTATIONS: - REVITAN SHAFT (DISTAL 18/200 MM, PROXIMAL 75 MM), RIGHT. - TRILOGY CUP 54 MM. - CROSSLINKED 36 MM INLAY. - BIOLOX HEAD 36 MM MIDDLE LENGTH AFTER EXPLANTATION OF THE HIP SPACER. SURGERY (B)(6) 2018: EXPLANTATIONS: - BIOLOX HEAD 36 MM . - PROXIMAL REVITAN COMPONENT BY HIP ARTHROTOMIE. - DISTAL REVITAN COMPONENT (18/200) BY KNEE ARTHROTOMIE WITH NOTCH WINDOWING AND PUSHING UP OF THE DISTAL REVITAN COMPONENT. IMPLANTATIONS: - ALLOCLASSIC SLL SIZE 9. - CERAMIC HEAD SHORT 36 MM. 7. ARE PRE- AND POST-OPERATIVE X-RAYS AVAILABLE? YES, X-RAYS ARE AVAILABLE IN THE CLINIC. 8. ARE THE IMPLANTATION AND REVISION REPORTS AVAILABLE? YES, IMPLANTATION AND REVISION REPORTS ARE AVAILABLE IN THE CLINIC. THE PATIENT ASKED FOR THE REPORTS ON (B)(6) 2018 AND SENT ON (B)(6) 2018. 9. CAN THE RETRIEVALS BE SENT FOR EXAMINATION? DUE TO DISCREPANCIES WITHIN THE PATIENT DOCUMENTATION IT IS UNCLEAR WHETHER THE PATIENT RECEIVED THE RETRIEVALS. HOWEVER, THIS CAN BE ASSUMED, AS THE RETRIEVALS ARE NOT STORED WITHIN THE CLINIC. - SURGICAL REPORT, DATED (B)(6) 2012: DIAGNOSIS: ENCLOSED SPACER CONDITION AFTER HTEP RIGHT, CONDITION AFTER PROXIMAL COVERING WITH CERCLAGE WIRES. TREATMENT: REMOVAL OF SPACER, REAMING OF FEMORAL CANAL, HISTOLOGY, DEBRIDEMENT, JETLAVAGE, INSERTION OF A NEW HTEP RIGHT CEMENTLESS. DESCRIPTION OF TREATMENT: NOTHING CONSPICUOUS RELEVANT TO THE REPORTED EVENT. - DOCTOR LETTER, DATED (B)(6) 2018: ANAMNESIS: PATIENT COMPLAINS ABOUT STINGING PAIN SINCE WEEKS IN THE RIGHT HIP. PATIENT FELL ON BLANK ICE ON (B)(6) 2018 AND ON (B)(6) 2018 PATIENT SUDDENLY BUCKLED. RIGHT HIP FINDINGS: LEG AXIS VARICOSE, LEG LENGTH BALANCED, EXTERNAL ROTATION MALPOSITION OF THE RIGHT LEG, NO PRESSURE PAIN, ANAMNESTIC PAIN OF VENTRAL THIGH DURING MOVEMENT AND LOAD. HIP JOINT MOBILITY EXTENSION/FLEXION 0-0-90°, INTERNAL ROTATION/EXTERNAL ROTATION 5-0-30° WITH PAIN IN INTERNAL ROTATION, ABDUCTION/ADDUCTION 3 5-0-20°, VIBRATIONAL PAIN IN THE AREA OF THE PROXIMAL FEMUR, ANVIL TEST POSITIVE. X-RAY: PERIPROSTHETIC FRACTURE DISTAL TO THE 2ND CERCLAGE WITH AXIAL KINK OF THE PROSTHESIS ON THE HEIGHT OF THE MODUALR CONNECTION. - SURGICAL REPORT, DATED (B)(6) 2018: DIAGNOSIS: DISTAL FEMUR FRACTURE RIGHT FOLLOWING IMPLANT REPLACEMENT RIGHT TREATMENT: OPEN REVISION AND ANGLE STABLE PLATE OSTEOSYNTHESIS USING A 18-HOLE NCP PLATE. SUMMARY OF DESCRIPTION OF PROCEDURE: UPON OPENING NO SECRETION OF A FRACTURE HEMATOMA. DISPLAY OF THE DISTAL FEMUR WITH THE FRACTURE ZONE ABOVE THE KNEE TEP. REDUCTION BY LONGITUDINAL TRACTION. SECURING THE FRACTURE REDUCTION WITH THREE LARGE FRAGMENT TRACTION SCREWS DISTAL TO THE PROSTHESIS. X-RAY CONTROL SHOWS THE FRACTURE IS COMPLETELY REDUCED. THE 18-HOLE NCP PLATE IS PLACED DISTAL TO THE FEMUR AND PUSHED PROXIMALLY TO THE HEIGHT OF THE PROSTHESIS. FIXATION WITH MULTIPLE SCREWS AND A CABLE WIRE. CLOSURE. - DISCHARGE LETTER, DATED (B)(6) 2018: DIAGNOSIS: REVITAN STEM FOLLOWING REVITAN REPLACEMENT RIGHT DUE TO CONUS FRACTURE POST-OPERATIVE DISTAL FEMORAL FRACTURE RIGHT FOLLOWING IMPLANT REPLACEMENT CONDITION AFTER SEPTIC HTEP REPLACEMENT RIGHT (B)(6) 2012. NO ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT. - REHABILITATION REPORT: PATIENT WAS STATIONARY IN ACURA RHÖNKLINIK GERSFELD FROM (B)(6) 2018. THE PATIENT WAS DISCHARGED BEING UNABLE TO WORK. THE TIME FRAME OF THE INCAPACITY TO WORK DEPENDS ON THE FURTHER BONY HEALING OF THE FRACTURE. THE REHABILITEE HAS BEEN ON SICK LEAVE SINCE (B)(6) 2018. THE PATIENT REPORTED HIP PAIN ON THE RIGHT AND KNEE PAIN ON THE RIGHT WITH SIGNIFICANT LIMITATION OF MOBILITY. PREVIOUS SURGERIES: MULTIPLE OPERATIONS (5X TEP CHANGES) ON THE RIGHT HIP. PRE-EXISTING CONDITIONS: BSV CERVICAL SPINE AND LUMBAR SPINE. HYPERTENSION KNOWN FOR YEARS, DIFFICULTY FALLING ASLEEP AND SLEEPING THROUGH, 174 CM, 97 KG, GENERAL PSYCHOLOGICAL FINDINGS: NO DEPRESSIVE MOOD, ADEQUATE WORDING GENERAL: DRESSING/UNDRESSING INDEPENDENTLY UNTIL SHOES/STOCKINGS FOR THIS THE PAT. NEEDS HELP. GAIT PATTERN: 2 FOREARM SUPPORTS. PELVIS STRAIGHTNESS. PROBLEMS: THE PATIENT PARTICIPATED ACTIVELY AND MOTIVATED IN THE PRESCRIBED THERAPY PROGRAM, WHICH WAS CARRIED OUT UNDER GRADUAL INCREASE IN EXERCISE INTENSITY WAS ESSENTIALLY WELL TOLERATED. THE MOBILITY SHOWED SLOW PROGRESS, AS WELL AS STRENGTH AND ENDURANCE PERFORMANCE IMPROVED. THE REQUIRED PARTIAL LOAD WAS MAINTAINED. STRENGTH AND MOBILITY IN THE OPERATED LEG ARE IMPROVED. MR. KEIDEL WOULD LIKE TO RESUME HIS WORK AGAINST OUR MEDICAL ADVICE. HE EXPECTS THE ASSIGNMENT OF WORK TASKS APPROPRIATE TO HIS CONDITION. - PSYCHOLOGICAL ASSESSMENT, DATED (B)(6) 2019: THE PATIENT HAS BEEN VISITING FOR TREATMENT SINCE (B)(6) 2016. DUE TO A CHRONIC PAIN SYNDROME A CHANGE IN PERSONALITY AND A MODERATE DEPRESSIVE EPISODE HAVE DEVELOPED, WHICH REQUIRE AN ANTIDEPRESSIVE DRUG THERAPY. - CHRONOLOGICAL ORDER OF GIVEN EVENTS: - PRIMARY HTEP IMPLANTATION IN 2007 DUE TO SECONDARY COXARHROSIS AFTER FEMORAL NECK FRACTURE. - (B)(6) 2010: EXPLANTATION OF THE HTEP DUE TO INFECTION OF HIP PROSTHESIS RIGHT WITH STAPHYLOCOCCUS EPIDERMIS - (B)(6) 2010: REIMPLANTATION WITH RECONSTRUCTION OF ACETABULUM DUE TO EXTENSIVE BONY DEFECTS. - (B)(6) 2012: RECURRENT INFECTION OF HTEP WITH STAPHYLOCOCCUS AUREUS. EXPLANTATION OF HTEP AND IMPLANTATION OF SPACER. - (B)(6) 2012: EXPLANTATION OF A HIP SPACER. IMPLANTATION OF A REVITAN REVISION SYSTEM, CUP, INLAY AND CERAMIC HEAD, ON THE RIGHT SIDE, DUE TO INFLAMMATION OF THE PREVIOUS PROSTHESIS. - (B)(6) 2013: X-RAY CONTROL DUE TO PAIN IN THE RIGHT HIP SHOWED CORRECT IMPLANT POSITIONING AND NO LOOSENING SEAM. - (B)(6) 2018: PATIENT FALL ON CLEAR ICE. PRIOR TO THAT THE PATIENT WAS FREE OF SYMPTOMS. WITH THE FALL MEDICAL CONDITIONS COMMENCED. - (B)(6) 2018: ACCORDING TO PATIENT, FRACTURE OF THE REVITAN CONE WHILE WALKING ON PLANE GROUND. - (B)(6) 2018: REVISION SURGERY OF FRACTURED REVITAN SYSTEM. INTRAOPERATIVELY, IT TURNED OUT THAT THE REVITAN SHAFT WAS LOOSE AND THE FRACTURE OCCURRED AT THE PIN, BEING PART OF THE DISTAL REVITAN COMPONENT, BETWEEN THE DISTAL AND THE PROXIMAL REVITAN COMPONENT. FURTHER, FORMATION OF AN AXIAL KINK WAS NOTICED. THE PROXIMAL REVITAN COMPONENT WAS RETRIEVED BY HIP ARTHROTOMIE. INTRAOPERATIVE COMPLICATIONS LED TO ARTHROTOMIE OF THE RIGHT KNEE JOINT IN ORDER TO PUSH OUT THE DISTAL REVITAN COMPONENT; FOLLOWING A FEMORAL FRACTURE OCCURRED. ADDITIONALLY, REMOVAL OF THE BIOLOX HEAD. IMPLANTATION OF AN ALLOCLASSIC SLL STEM, SIZE 9 WITH A CERAMIC HEAD 36 MM. - (B)(6) 2018: SURGERY FOR TREATMENT OF THE FEMORAL FRACTURE FROM THE PREVIOUS SURGERY ON (B)(6) 2018. OPEN REDUCTION AND TREATMENT WITH ANGLE STABLE NCP PLATE AND PROXIMAL CERCLAGE WIRE. - (B)(6) 2018: REHABILITATION TREATMENT, HOWEVER, PATIENT IS RELEASED INCAPABLE OF WORKING. - UNTIL (B)(6) 2018: PATIENT ABLE TO MOVE WITH THE HELP OF FOREARM CRUTCHES ONLY. - UNTIL (B)(6) 2019: WALKING DISTANCE WAS SUCCESSIVELY INCREASED TO 1.5 KM. BUT PATIENT IS COMPLAINING ABOUT KNEE PAIN SINCE TWO WEEKS. NATIVRADIOLOGICAL DETECTION OF A MEDIALLY ACCENTUATED CHONDROPATHY OF THE KNEE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. MOST LIKELY, THE RETRIEVALS ARE WITH THE PATIENT. REVIEW OF PRODUCT DOCUMENTATION: - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: IN A PATIENT A HIP SPACER WAS REMOVED AND A REVITAN REVISION SYSTEM WAS IMPLANTED ON THE RIGHT SIDE ON (B)(6) 2012. ACCORDING TO THE PATIENT THE REVITAN PROSTHESIS FRACTURED DURING A WALK. HOWEVER, ACCORDING TO THE MEDICAL RECORDS, THE PATIENT EXPERIENCED A FALL ON CLEAR ICE ON (B)(6) 2018 AFTER WHICH THE MEDICAL CONDITIONS STARTED. BEFORE THE FALL THE PATIENT REPORTED TO BE FREE OF SYMPTOMS. ON (B)(6) 2018 THE PATIENT WAS REVISED TO TREAT THE FRACTURED IMPLANT. INTRAOPERATIVE FINDINGS SHOWED THAT THE REVITAN STEM WAS LOOSE AND FRACTURED AT THE PIN BETWEEN THE DISTAL AND THE PROXIMAL REVITAN COMPONENT. THE PROXIMAL REVITAN COMPONENT WAS RETRIEVED BY HIP ARTHROTOMIE. INTRAOPERATIVE COMPLICATIONS LED TO ARTHROTOMIE OF THE RIGHT KNEE JOINT IN ORDER TO PUSH OUT THE DISTAL REVITAN COMPONENT; FOLLOWING A FEMORAL FRACTURE OCCURRED. ANOTHER HIP SYSTEM WAS IMPLANTED. ONE WEEK LATER, ON (B)(6) 2018, AN ADDITIONAL SURGERY TOOK PLACE IN ORDER TO TREAT THE FEMORAL FRACTURE FROM THE PREVIOUS SURGERY ((B)(6) 2018). AN OPEN REDUCTION AND TREATMENT WITH ANGLE STABLE NCP PLATE AND PROXIMAL CERCLAGE WIRE WAS PERFORMED. POST-OPERATIVE THE PATIENT TOOK PLACE IN REHABILITATION TREATMENT FOR ALMOST ONE MONTH, HOWEVER, THE PATIENT WAS RELEASED INCAPABLE OF WORKING. FOR ANOTHER 1.5 MONTHS AFTER REHABILITATION THE PATIENT NEEDED CRUTCHES TO MOVE. AN X-RAY FOLLOW-UP COVERING THE TIME IN-VIVO HAS NOT BEEN RECEIVED. IN ADDITION, THE RETRIEVALS WERE NOT RECEIVED FOR INVESTIGATION. THEREFORE, THE CONDITION OF THE IMPLANTS IS UNKNOWN AND AN IN-DEPTH INVESTIGATION OF THE FAILURE MODE WAS IMPOSSIBLE. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. IN CONCLUSION, BASED ON THE GIVEN INFORMATION AN IN-DEPTH ANALYSIS COULD NOT BE PERFORMED, THEREFORE, AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION HAS BEEN RECEIVED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
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: A PATIENT WAS IMPLANTED WITH A REVITAN REVISION SYSTEM ON THE RIGHT SIDE ON(B)(6) 2012. IN (B)(6) 2018 THE REVITAN PROSTHESIS FRACTURED DURING A WALK. THE REVISION TOOK PLACE ON THE (B)(6) 2018. DURING THE REVISION THERE WERE COMPLICATIONS TO RETRIEVE THE DISTAL REVITAN COMPONENT, DUE TO WHICH AN ARTHRONOMIE ON THE RIGHT KNEE JOINT WAS PERFORMED. FOLLOWING, DURING REMOVAL OF THE DISTAL PROSTHESIS A FRACTURE OF THE FEMUR OCCURRED. ANOTHER SURGERY TOOK PLACE ON THE (B)(6) 2018 TO TREAT THE FEMORAL BONE FRACTURE. REVIEW OF RECEIVED DATA: - LEGAL LETTER FROM (B)(6) , 2018: FACTS OF THE CASE: - IMPLANTATION OF A REVITAN REVISION SYSTEM (ZIMMER PRODUCTS) ON THE RIGHT SIDE ON (B)(6) 2012 AFTER REMOVAL OF THE PREVIOUS PROSTHESIS DUE TO INFLAMMATION. THE REVITAN REVISION SYSTEM CONSISTS OF A REVITAN DISTAL CURVED, REF: (B)(4). REVITAN PROXIMAL SPOUT UNCEMENTED, REF: (B)(4) PRODUCT STICKERS ARE AVAILABLE. ON (B)(6) 2018 THE PROSTHESIS FRACTURED AT THE CONE WHILE NORMAL WALKING ON PLANE GROUND. ON (B)(6) 2018 REVISION SURGERY TOOK PLACE AT THE "ORTHOPÄDISCHES KRANKENHAUS SCHLOSS WERNECK". INTRAOPERATIVELY, IT WAS FOUND THAT THE REVITAN SHAFT WAS LOOSE AND FRACTURED EXACTLY AT THE CONE. FOLLOWING COMPLICATIONS OCCURRED. AN ARTHROTOMIE FOLLOWED AT THE RIGHT KNEE JOINT THEREBY THE DISTAL SHAFT PROSTHESIS WAS PUSHED UPWARDS AND A FEMUR FRACTURE OCCURRED DUE TO WHICH ANOTHER SURGERY TOOK PLACE ON (B)(6) 2018. DURING THE PERIOD OF (B)(6) 2018 THE PATIENT TOOK PLACE IN A REHABILITATION TREATMENT. HOWEVER, THE PATIENT WAS RELEASED BEING INCAPABLE OF WORKING. TILL (B)(6) 2018 THE PATIENT COULD ONLY MOVE WITH THE HELP OF FOREARM CRUTCHES. - LETTER FROM PROF. DR. (B)(6) ANSWERING FOLLOW UP QUESTIONS: 1. AT WHICH SITE DID THE IMPLANT FRACTURE? THE REVITAN REVISION SYSTEM FRACTURED AT THE SCREW CONNECTION/CONE BETWEEN THE PROXIMAL CONICAL COMPONENT AND THE DISTAL CURVED COMPONENT WITH AXIAL KINK FORMATION. 2. WERE ANY PIECES OF THE BROKEN DEVICE REMAINING IN THE PATIENT? NO IMPLANT PIECES REMAINED WITHIN THE PATIENT. 3. DID THE PATIENT HAVE COMPLICATIONS DURING SURGERY OR AFTER THE SURGERY? WHAT KIND OF COMPLICATIONS? THE PATIENT EXPERIENCED COMPLICATIONS DURING THE SURGERY CONSISTING OF A DISTAL FEMORAL NECK FRACTURE ON THE RIGHT SIDE FOLLOWED BY AN OPEN REPOSITION AND INSERTION OF AN ANGLE STABLE PLATE OSTEOSYNTHESIS WITH NCP PLATE AND PROXIMAL CERCLAGE WIRE ON (B)(6) 2018. 4. WHY WAS THERE AN ARTHROTOMIE IN THE RIGHT KNEE JOINT WHEN THE IMPLANTS ARE FOR THE HIPS? TO RETRIEVE THE DISTAL REVITAN COMPONENT. ARTHROTOMIE OF THE RIGHT KNEE JOINT WITH WINDOWING OF THE FEMORAL MEDULLARY CAVITY IN THE AREA OF THE NOTCH AND SUBSEQUENTLY PUSHING UP OF THE DISTAL SHAFT PROSTHESIS ON (B)(6) 2018. 5. HOW DID THE FRACTURE OF THE RIGHT FEMUR OCCUR AND WAS IT DEVICE RELATED? POSSIBLY THE FRACTURE OCCURRED DUE TO A PATIENT FALL ON CLEAR ICE IN(B)(6) 2018, AS, CONCERNING THE STATEMENT OF THE PATIENT, AT THIS TIME POINT THE MEDICAL CONDITIONS STARTED. PRIOR TO THAT THE PATIENT WAS FREE OF SYMPTOMS. THE FRACTURE OF THE DISTAL FEMUR OCCURRED MOST LIKELY INTRAOPERATIVELY THROUGH THE NECESSARY WINDOWING AND THE PUSHING OUT OF THE DISTAL REVITAN COMPONENT. 6. WHAT WAS IMPLANTED/EXPLANTED IN EACH SURGERY? SURGERY (B)(6) 2012: EXPLANTATIONS: - HIP SPACER IMPLANTATIONS: - REVITAN SHAFT (DISTAL 18/200 MM, PROXIMAL 75 MM), RIGHT - TRILOGY CUP 54 MM - CROSSLINKED 36 MM INLAY - BIOLOX HEAD 36 MM MIDDLE LENGTH AFTER EXPLANTATION OF THE HIP SPACER. SURGERY (B)(6) 2018: EXPLANTATIONS: - BIOLOX HEAD 36 MM - PROXIMAL REVITAN COMPONENT BY HIP ARTHROTOMIE - DISTAL REVITAN COMPONENT (18/200) BY KNEE ARTHROTOMIE WITH NOTCH WINDOWING AND PUSHING UP OF THE DISTAL REVITAN COMPONENT. IMPLANTATIONS: - ALLOCLASSIC SLL SIZE 9 - CERAMIC HEAD SHORT 36 MM 7. ARE PRE- AND POST-OPERATIVE X-RAYS AVAILABLE? YES, X-RAYS ARE AVAILABLE IN THE CLINIC. 8. ARE THE IMPLANTATION AND REVISION REPORTS AVAILABLE? YES, IMPLANTATION AND REVISION REPORTS ARE AVAILABLE IN THE CLINIC. THE PATIENT ASKED FOR THE REPORTS ON (B)(6) 2018 AND SENT ON (B)(6) 2018. 9. CAN THE RETRIEVALS BE SENT FOR EXAMINATION? DUE TO DISCREPANCIES WITHIN THE PATIENT DOCUMENTATION IT IS UNCLEAR WHETHER THE PATIENT RECEIVED THE RETRIEVALS. HOWEVER, THIS CAN BE ASSUMED, AS THE RETRIEVALS ARE NOT STORED WITHIN THE CLINIC. - CHRONOLOGICAL ORDER OF GIVEN EVENTS: (B)(6) 2012: EXPLANTATION OF A HIP SPACER IMPLANTATION OF A REVITAN REVISION SYSTEM, CUP, INLAY AND CERAMIC HEAD, ON THE RIGHT SIDE, DUE TO INFLAMMATION OF THE PREVIOUS PROSTHESIS. (B)(6) 2018: ACCORDING TO SURGEON, PATIENT FALL ON CLEAR ICE. PRIOR TO THAT THE PATIENT WAS FREE OF SYMPTOMS. WITH THE FALL MEDICAL CONDITIONS COMMENCED. (B)(6) 2018: ACCORDING TO PATIENT, FRACTURE OF THE REVITAN CONE WHILE WALKING ON PLANE GROUND. (B)(6) 2018: REVISION SURGERY OF FRACTURED REVITAN SYSTEM. INTRAOPERATIVELY, IT TURNED OUT THAT THE REVITAN SHAFT WAS LOOSE AND THE FRACTURE OCCURRED AT THE PIN, BEING PART OF THE DISTAL REVITAN COMPONENT, BETWEEN THE DISTAL AND THE PROXIMAL REVITAN COMPONENT. FURTHER, FORMATION OF AN AXIAL KINK WAS NOTICED. THE PROXIMAL REVITAN COMPONENT WAS RETRIEVED BY HIP ARTHROTOMIE. INTRAOPERATIVE COMPLICATIONS LED TO ARTHROTOMIE OF THE RIGHT KNEE JOINT IN ORDER TO PUSH OUT THE DISTAL REVITAN COMPONENT; FOLLOWING A FEMORAL FRACTURE OCCURRED. ADDITIONALLY, REMOVAL OF THE BIOLOX HEAD. IMPLANTATION OF AN ALLOCLASSIC SLL STEM, SIZE 9 WITH A CERAMIC HEAD 36 MM. (B)(6) 2018: SURGERY FOR TREATMENT OF THE FEMORAL FRACTURE FROM THE PREVIOUS SURGERY ON (B)(6) 2018. OPEN REDUCTION AND TREATMENT WITH ANGLE STABLE NCP PLATE AND PROXIMAL CERCLAGE WIRE. (B)(6) 2018: REHABILITATION TREATMENT, HOWEVER, PATIENT IS RELEASED INCAPABLE OF WORKING. - UNTIL (B)(6) 2018: PATIENT ABLE TO MOVE WITH THE HELP OF FOREARM CRUTCHES ONLY. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. MOST LIKELY, THE RETRIEVALS ARE WITH THE PATIENT. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION: IN A PATIENT A HIP SPACER WAS REMOVED AND A REVITAN REVISION SYSTEM WAS IMPLANTED ON THE RIGHT SIDE ON (B)(6) 2012. ACCORDING TO THE PATIENT THE REVITAN PROSTHESIS FRACTURED DURING A WALK. HOWEVER, ACCORDING TO THE SURGEON, THE PATIENT EXPERIENCED A FALL ON CLEAR ICE AFTER WHICH THE MEDICAL CONDITIONS STARTED. BEFORE THE FALL THE PATIENT REPORTED TO BE FREE OF SYMPTOMS. ON (B)(6) 2018 THE PATIENT WAS REVISED TO TREAT THE FRACTURED IMPLANT. INTRAOPERATIVE FINDINGS SHOWED THAT THE REVITAN STEM WAS LOOSE AND FRACTURED AT THE PIN BETWEEN THE DISTAL AND THE PROXIMAL REVITAN COMPONENT. THE PROXIMAL REVITAN COMPONENT WAS RETRIEVED BY HIP ARTHROTOMIE. INTRAOPERATIVE COMPLICATIONS LED TO ARTHROTOMIE OF THE RIGHT KNEE JOINT IN ORDER TO PUSH OUT THE DISTAL REVITAN COMPONENT; FOLLOWING A FEMORAL FRACTURE OCCURRED. ANOTHER HIP SYSTEM WAS IMPLANTED. ONE WEEK LATER, ON (B)(6) 2018, AN ADDITIONAL SURGERY TOOK PLACE IN ORDER TO TREAT THE FEMORAL FRACTURE FROM THE PREVIOUS SURGERY(B)(6) 2018). AN OPEN REDUCTION AND TREATMENT WITH ANGLE STABLE NCP PLATE AND PROXIMAL CERCLAGE WIRE WAS PERFORMED. POST-OPERATIVE THE PATIENT TOOK PLACE IN REHABILITATION TREATMENT FOR ALMOST ONE MONTH, HOWEVER, THE PATIENT WAS RELEASED INCAPABLE OF WORKING. FOR ANOTHER 1.5 MONTHS AFTER REHABILITATION THE PATIENT NEEDED CRUTCHES TO MOVE. X-RAYS AND SURGICAL NOTES FOR THE IMPLANTATION, THE FOLLOW-UP AND THE REVISION WERE REQUESTED, HOWEVER, NOT RECEIVED FOR INVESTIGATION. THEREFORE, NO INFORMATION ABOUT THE MEDICAL SITUATION FROM THE TIME PRIOR TO IMPLANTATION UNTIL REVISION IS AVAILABLE. FURTHER, THE RETRIEVALS WERE NOT RECEIVED FOR INVESTIGATION. THEREFORE, THE CONDITION OF THE IMPLANTS IS UNKNOWN AND AN IN-DEPTH INVESTIGATION OF THE FAILURE MODE WAS IMPOSSIBLE. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. IN CONCLUSION, BASED ON THE SIGNIFICANT LACK OF INFORMATION AN IN-DEPTH ANALYSIS COULD NOT BE PERFORMED. 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 (B)(6) 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).
NOTE: THIS FOLLOW UP REPORT HAS BEEN CREATE TO REFLECT THE ADDITIONAL INFORMATION WE RECEIVED. THE ADDITIONAL INFORMATION HAS BEEN REVIEWED AND THE INVESTIGATION OF THIS INCIDENT HAS BEEN RE-ASSESSED AND UPDATED.
NO EVENT UPDATE.
NO EVENT UPDATE.
THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (K071723) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: ITEM NUMBER: 0100401075, ITEM NAME: REVITAN PROX. SPOUT 75, LOT # 2603542. ITEM NUMBER: 00-6200-064-20, ITEM NAME: TRILOGY FM ACET SHL 64 OD UNIV, LOT # 61878442. ITEM NUMBER: 00-6250-065-25, ITEM NAME: TRILOGY BONE SCR 6.5X25, LOT # 62011529. ITEM NUMBER: 00-6250-065-25, ITEM NAME: TRILOGY BONE SCR 6.5X25, LOT # 62037915. ITEM NUMBER: 00-6305-064-36, ITEM NAME: XLPE 0 DEG POLY LINER 64X36, LOT # 61817209. ITEM NUMBER: 00-8775-036-02, ITEM NAME: BIOLOX DELTA HEAD 12/14 36X0, LOT # 2645296. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. (B)(4).
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM FOLLOWING A REVISION SURGERY DUE TO IMPLANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 928890 | REVITAN DIST. CURVED 18/200 | N/A | KWA | ZIMMER GMBH | N/A | 2619768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |