REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/260
Report
- Report Number
- 0009613350-2019-00014
- Event Type
- Injury
- Date Received
- January 10, 2019
- Date of Event
- May 16, 2018
- Report Date
- February 5, 2020
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- 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
ADDITIONAL INFORMATION HAS BEEN RECEIVED. D11, CONCOMITANT DEVICES: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 105, TAPER 12/14, ITEM: 01.00402.105 LOT#: 2925532. BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 32/+7, TAPER 12/14ITEM: 00-8775-032-04 LOT#: 2935013. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
NEW INFORMATION HAS BEEN MADE AVAILABLE: - NEW PRODUCT, 01.0000.662 CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: - NAME: G7 PPS LTD ACET SHELL 50D ITEM: 01.0000.662 LOT#: 3654474 THE INVESTIGATION RESULTS WILL BE UPDATED. AS SOON AS THE UPDATED INVESTIGATION RESULTS BECOME AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2019 - 00015 - 3.
INVESTIGATION RESULTS HAVE BEEN UPDATED. CORRECTION: B4, G4, G7, H10. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: IMPLANT MIGRATION. NO LOT TREND HAS BEEN FOUND. DEVICE HISTORY RECORDS (DHR): REF#: 01.00406.316 LOT#: 2921641. YIELD: 20. DELIVERED: 20. SCRAPPED: 0. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: 01.00402.105 LOT#: 2925532. YIELD: 13. DELIVERED: 13. SCRAPPED: 0. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: THIS COMPLAINT WAS REGISTERED UPON RECEPTION OF A WRIT BY THE LEGAL DEPARTMENT. ACCORDING TO THE WRIT AND ADDITIONAL SOURCES THE MALE PATIENT P.V. UNDERWENT THE BELOW MENTIONED PROCEDURES. THIS COMPLAINT COVERS THE REVITAN REVISION PERFORMED ON (B)(6) 2018 WHICH WAS MENTIONED IN THE LEGAL WRIT. WITHIN THE SUMMARY ZUSAMMENFASSUNG_GESCHWÄRZT RECEIVED IT IS MENTIONED THAT THIS REVITAN REVISION WAS PERFORMED DUE TO STEM SINTERING. SUMMARY OF PROCEDURE: 2005: INITIAL LEFT HIP TEP WITH UNKNOWN DEVICES. ON (B)(6) 2015: PATIENT FALL ON LEFT HIP. ON (B)(6) 2015: REMOVAL OF LEFT HIP TEP AND REPLACEMENT WITH CEMENT SPACER (GIRDLESTONE SITUATION) DUE TO INFECTION. ON (B)(6) 2015: INFECTION AND OUTBURST OF CEMENT SPACER. ON (B)(6) 2015: OPEN BIOPSY, DEBRIDEMENT AND LAVAGE, NO INDICATION FOR INFECTION. ON (B)(6) 2015: IMPLANTATION OF HYPERION REVISION HIP TEP (WARSAW PRODUCTS: HYPERION STEM, BIOLOX DELTA, ACETABULAR LINER, ACETABULAR G7 SHELL). ON (B)(6) 2015: REVISION OF HYPERION STEM AND HEAD DUE TO LUXATION, STEM LOOSENING AND PERIPROSTHETIC FRACTURE ((B)(4)). IMPLANTATION OF ANOTHER HYPERION STEM, ACETABULAR LINER, BIOBALL ADAPTER AND BIOBALL DELTA CERAMIC HEAD AND WIRE CERCLAGE. ON (B)(6) 2018: IMPLANT FRACTURE OF HYPERION STEM DUE TO TRAUMA (TWISTING MOTION) ((B)(4)) NOTICED. ON (B)(6) 2018: REVISION OF FRACTURED HYPERION STEM ((B)(4)) TO A REVITAN SYSTEM (REVITAN PROX, REVITAN DIST. CURVED, BIOLOX DELTA HEAD). ON (B)(6) 2018: REVISION OF REVITAN SYSTEM DUE TO STEM SINTERING ((B)(4)). IMPLANTATION OF ANOTHER REVITAN SYSTEM AND A BIOLOX HEAD. ON (B)(6) 2018: CLOSED REPOSITION DUE TO TRAUMA (TWISTING MOTION) ((B)(4)). ON (B)(6) 2018: REVISION OF ACETABULAR SHELL AND HEAD DUE TO RECURRING LUXATIONS ((B)(4)). IMPLANTATION OF AN AVANTAGE ACETABULAR CUP, BIOLOX OPTION TAPER, BIOLOX DELTA HEAD, TRABECULAR METAL SHELL AND MULTIPLE BONE SCREWS. ON (B)(6) 2018: SURGERY DUE TO INFECTION OF THE LESION WITH MICROBIOLOGICAL AND HISTOPATHOLOGICAL INVESTIGATION ((B)(4)). ON (B)(6) 2018: FOLLOW-UP CHECK: NO INDICATION FOR INFECTION, ON-GOING ANTIBIOSIS, FULL WEIGHT BEARING. ON (B)(6) 2018: FOLLOW-UP CHECK: NO INDICATION FOR INFECTION, ON-GOING ANTIBIOSIS, FULL WEIGHT BEARING ((B)(4)). REVIEW OF RECEIVED DATA IN TOTAL 18 X-RAYS WERE RECEIVED FOR REVIEW: 2 X (B)(6) 2015: PERIPROSTHETIC FRACTURE WITH BONE DISLOCATION PELVIS OVERVIEW, LEFT HIP AXIAL-VIEW: SITUATION AFTER FRACTURE TROCHANTER MINOR- AND MAJOR-COMPLEX SHOWING INCOMPLETE FRACTURE HEALING MEDIALLY IN THE AREA OF THE DISTAL PART OF THE PROSTHESIS. MEDIALLY AT THE LEVEL OF THE PROXIMAL PART OF THE PROSTHESIS RECOGNIZABLE LARGER RADIOLUCENT AREA, LATERALLY OVER HALF OF THE PROXIMAL PART OF THE PROSTHESIS IS MISSING BONY SUPPORT. 1 X (B)(6) 2018: FRACTURE OF HYPERION STEM (DELIVERED WITH LEGAL WRIT) PELVIS OVERVIEW, SHOWING THE HYPERION STEM. POOR IMAGE QUALITY. 4 X (B)(6) 2018: REPOSITIONED BONE FRAGMENTS USING CERCLAGE WIRES AND FIXED BONE WINDOW IN THE DISTAL FEMUR USING A CERCLAGE WIRE PELVIS OVERVIEW, LEFT FEMUR WITH KNEE JOINT AP/LATERAL-VIEW, LEFT HIP WITH FEMUR LAUENSTEIN-VIEW: CONDITION AFTER REVISION SURGERY WITH IMPLANTATION OF A REVITAN STEM ON THE LEFT SIDE. COMPARED TO THE PREVIOUS X-RAYS DATED (B)(6) 2015 THE LARGER TROCHANTER FRAGMENT IS ATTACHED MEDIALLY, ADDITIONALLY FIXED WITH CERCLAGE WIRES. LATERALLY, THE BONY SUPPORT IS MISSING OVER A DISTANCE OF TWO THIRDS OF THE PROXIMAL PART OF THE STEM. IN THE AREA OF THE DISTAL PROSTHESIS PART BETWEEN THE CONNECTION POINT AND THE LOWER TWO CERCLAGE WIRES RECOGNIZABLE RADIOLUCENT LINE MEDIALLY AND LATERALLY OF THE STEM. DISTAL MEDIALLY RECOGNIZABLE OSSEOUS SPLIT OF THE CORTICALIS. RADIOLUCENT AREA IDENTIFIABLE ON THE LAUENSTEIN-VIEW AT THE LEVEL OF THE PROXIMAL PART OF THE PROSTHESIS ANTEROMEDIAL AND ANTEROLATERAL. 3 X (B)(6) 2018: X-RAYS OF DISLOCATION AND REPOSED HIP: PELVIS OVERVIEW, LEFT HIP LAUENSTEIN-VIEW, LEFT FEMUR WITH KNEE JOINT AP: DISLOCATION OF THE LEFT FEMUR HEAD. COMPARED TO THE PREVIOUS X-RAYS DATED (B)(6) 2018 UNCHANGED MISSING BONY SUPPORT ON THE LATERAL SIDE OF THE PROXIMAL PART OF THE STEM AND A SPLIT LINE OF THE MEDIAL CORTICALIS DISTAL WITH RECOGNIZABLE DISTRACTION OF THE FRACTURE GAP. 2 X (B)(6) 2018: X-RAY FOLLOW-UP: PELVIS OVERVIEW, LEFT HIP LAUENSTEIN-VIEW: COMPARED TO THE PREVIOUS X-RAYS DATED (B)(6) 2018 UNCHANGED MISSING BONY SUPPORT LATERAL PROXIMAL, UNCHANGED VISIBLE SPLIT LINE OF THE MEDIAL CORTICALIS DISTAL. UNCHANGED BONE LOSS PROXIMAL LATERALLY. CERCLAGE WIRES AND PROSTHESIS SEEMS UNDAMAGED. IN THE LAUENSTEIN-VIEW A LARGE RADIOLUCENT AREA POSTEROMEDIAL AT THE LEVEL OF THE PROXIMAL PART OF THE PROSTHESIS VISIBLE. 4 X (B)(6) 2018: X-RAYS OF DISLOCATION AND REPOSED HIP: PELVIS OVERVIEW AND LEFT HIP AXIAL, PELVIS OVERVIEW AFTER REPOSITION, LEFT HIP WITH FEMUR AP: DISLOCATION OF THE LEFT HIP. 3 X (B)(6) 2018: X-RAYS OF DISLOCATION AND REPOSED HIP: PELVIS OVERVIEW BEFORE FEMORAL HEAD DISLOCATION, PELVIS OVERVIEW WITH HEAD DISLOCATION, PELVIS OVERVIEW AFTER REPOSITION CONCLUSION: THE PRESENT X-RAY DOCUMENTATION OF (B)(6) 2018 SHOWS AN IMPLANTED REVITAN STEM ON THE LEFT SIDE WITH A CUP INCLINATION ANGLE OF ABOUT 49°. COMPARED TO THE PREVIOUS X-RAYS DATED (B)(6) 2015 THE LARGER TROCHANTER FRAGMENT IS ATTACHED MEDIALLY, ADDITIONALLY FIXED BY CERCLAGE WIRES. UNCHANGED BONE LOSS OVER A DISTANCE OF TWO THIRDS OF THE PROXIMAL PART OF THE STEM AND DISTAL MEDIALLY RECOGNIZABLE OSSEOUS SPLIT OF THE CORTICALIS. 6 DAYS LATER, ON (B)(6) 2018 RADIOLOGICALLY A DISLOCATION OF THE LEFT FEMUR HEAD CAN BE SEEN. COMPARED TO THE PREVIOUS X-RAYS DATED (B)(6) 2018 UNCHANGED MISSING BONY SUPPORT ON THE LATERAL SIDE OF THE PROXIMAL PART OF THE STEM. TAKING INTO ACCOUNT THE RADIOLOGICALLY DIFFERENT SIZE AND ROTATION RATIOS, A CHANGE IN POSITION DUE TO SINKING OF THE PROSTHESIS SHAFT CAN BE SEEN DISTALLY. THEREBY, ALSO VISIBLE ENLARGEMENT OF THE FRACTURE GAP ON THE MEDIAL FEMORAL CORTICALIS. ACCORDING TO THE AVAILABLE INFORMATION, A REVISION SURGERY WITH IMPLANTATION OF A NEW REVITAN STEM WAS PERFORMED. THE PRESENT X-RAY DOCUMENTATION OF (B)(6) 2018 SHOWS THE IMPLANTED REVITAN STEM ON THE LEFT SIDE WITH A CUP INCLINATION ANGLE OF ABOUT 48°. TAKING INTO ACCOUNT THE PRESENT FILE SITUATION, NO IMPLANT-RELATED CAUSES FOR THE RECURRENT DISLOCATION OF THE LEFT HIP CAN BE IDENTIFIED. RADIOLOGICALLY CORRECT POSITION OF THE IMPLANTED REVITAN STEM AND CORRECT CUP POSITION. AFTER IMPLANTATION OF THE REVITAN ON (B)(6) 2018 WITH RADIOLOGICAL FOLLOW-UP 2 DAYS LATER ON (B)(6) 2018, A RADIOGRAPHIC DISLOCATION OF THE LEFT FEMORAL HEAD CAN BE DETERMINED ON THE BASIS OF THE AVAILABLE DOCUMENTS. TAKING INTO ACCOUNT THE COMPARATIVE X-RAYS FROM (B)(6) 2018, IT CAN BE ASSUMED BIOMECHANICALLY THAT, MOST LIKELY, A DISTALIZATION OF THE PROSTHESIS STEM OCCURRED DURING DISLOCATION, WHICH CONSEQUENTLY LED TO THE DISTRACTION OF THE FRACTURE FRAGMENTS. SURGICAL REPORTS: THE SURGICAL REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6) 2015 DUE TO LUXATION, STEM LOOSENING AND PERIPROSTHETIC FRACTURE WAS RECEIVED. HOWEVER, THIS SURGICAL REPORT COVERS AN EARLIER EVENT AND DOES NOT CONTAIN WINTERTHUR PRODUCTS, THEREFORE, NO DETAILED REVIEW WAS PERFORMED. THE SURGICAL REPORT OF THE REVISION PERFORMED ON (B)(6) 2018 DUE TO IMPLANT FRACTURE WAS RECEIVED. THIS SURGICAL REPORT COVERS THE REVISION PERFORMED PRIOR TO THE REVISION PERFORMED ON (B)(6) 2018 (SUBJECT TO THIS COMPLAINT). THE FOLLOWING DEVICES WERE IMPLANTED: REF: 01.00402.105, LOT: 2925532: REVITAN PROX. UNCEMENTED 105 MM. REF: 01.00406.316, LOT: 2921641: REVITAN DIST. UNCEMENTED 16/260 MM. REF: 00-8775-032-04, LOT: 2935013: BIOLOX DELTA HEAD. DESCRIPTION OF PROCEDURE: REMOVAL OF THE HYPERION STEM BY MEANS OF A FEMORAL OSTEOTOMY VIA THE ISTHMUS. FOLLOWED BY MULTI-DIMENSIONAL OSTEOTOMY OF THE WRONGLY ROTATED HEALED TROCHANTER MAJOR AND MINOR. FINALLY, REPOSITION AND FIXATION OF THE OSTEOTOMY USING CERCLAGE WIRES. REAMING UNTIL SIZE 14. RASPING UNTIL SIZE 16. A REVITAN DISTAL 16/260 MM AND A REVITAN PROXIMAL 105 MM COMPONENT ARE MOUNTED EXTERNALLY AND INSERTED INTO THE FEMUR. A MODERATE FIT IS REACHED DUE TO THE OSTEOTOMY IN THE AREA OF THE ISTHMUS. MOUNTING OF A 32 MM CERAMIC XL HEAD. REPOSITION. STABLE JOINT GUIDANCE WITHOUT LUXATION TENDENCY. LAVAGE WITH LAVASEPT AND RINGER-SOLUTION. THE PER FILED FOR THE HYPERION IMPLANT FRACTURE ((B)(4)) FOUND ON (B)(6) 2018 AND REVISED ON (B)(6) 2018 CONTAINS THE FOLLOWING PATIENT INFORMATION: MALE PATIENT WITH INITIALS P.V., BORN ON (B)(6) 1954. HEIGHT 182 CM. WEIGHT 100 KG. ADDITIONALLY, THE SURGICAL REPORT OF (B)(6) 2018 DUE TO STEM SINTERING HAS BEEN RECEIVED: DIAGNOSIS: STEM SINTERING LEFT SIDE, LEFT HIP TEP LUXATION TREATMENT: REVISION OF REVITAN STEM AND HEAD AND OSTEOSYNTHESIS WITH CERCLAGE WIRES INDICATION: DURING THE POST OPERATIVE COURSE OF EVENTS THE PATIENT EXPERIENCED A STEM SINTERING. DUE TO JOINT LAXITY A HIP LUXATION OCCURRED. THEREFORE, INDICATION FOR SURGICAL TREATMENT GIVEN. NO ADDITIONAL RELEVANT INFORMATION IN THE DESCRIPTION OF THE PROCEDURE FOUND. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE: A COMPARISON OF THE APPLICABLE SURGICAL TECHNIQUE AND THE PERFORMED PROCEDURE COULD NOT BE PERFORMED, AS THE SURGICAL REPORT OF (B)(6) 2018 CONTAINS A VERY SHORT DESCRIPTION OF THE PERFORMED PROCEDURE ONLY. CONCLUSION SUMMARY: ACCORDING TO THE PROVIDED DATA THE PATIENT WAS IMPLANTED WITH A REVITAN STEM ON (B)(6) 2018. ON THE THREE X-RAYS DATED (B)(6) 2018 A DISLOCATION IS VISIBLE. ON (B)(6) 2018 THE REVITAN STEM WAS REVISED TO ANOTHER REVITAN STEM DUE TO STEM SINTERING. TAKING INTO ACCOUNT THE PRESENT X-RAY DOCUMENTATION, NO IMPLANT-RELATED CAUSES FOR THE RECURRENT DISLOCATION OF THE LEFT HIP CAN BE IDENTIFIED. RADIOLOGICALLY CORRECT POSITION OF THE IMPLANTED REVITAN STEM AND CORRECT CUP POSITION WAS FOUND. HOWEVER, LATERALLY BONY SUPPORT IS MISSING OVER A DISTANCE OF TWO THIRDS OF THE HEIGHT OF THE PROXIMAL REVITAN COMPONENT AND DISTAL MEDIALLY A FRACTURE THROUGH THE CORTICALIS CAN BE SEEN. ON (B)(6) 2018 IN THE AREA OF THE DISTAL PROSTHESIS PART RECOGNIZABLE RADIOLUCENT LINE MEDIALLY AND LATERALLY OF THE STEM. BASED ON THE COMPARISON OF SPECIFIC LANDMARKS ON X-RAYS DATED (B)(6) 2018 AND X-RAY (B)(6) 2018, A SHIFT INTO DISTAL DIRECTION OF THE STEM CAN BE RECOGNIZED. MOST LIKELY, THE CHANGE IN POSITION OCCURRED DURING DISLOCATION. ACCORDING TO THE SURGICAL REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6) 2018, A JOINT LAXITY AND A HIP LUXATION HAS BEEN PRESENT SINCE THE PREVIOUS REVISION (B)(6) 2018. 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 AVAILABLE X-RAYS AND THE PATIENT ANAMNESIS, IT IS LIKELY THAT THE DISLOCATION LED TO THE SINTERING OF THE STEM. IN ADDITION, PATIENT FACTORS SUCH AS PREVIOUS DISLOCATIONS AND SURGICAL TREATMENTS, WEIGHT AND COMPLIANCE TO REHABILITATION PROTOCOL MAY HAVE NEGATIVELY INFLUENCED THE PERFORMANCE OF THE DEVICE. NEVERTHELESS, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'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. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: IMPLANT MIGRATION. EVENT SUMMARY: THIS COMPLAINT WAS REGISTERED UPON RECEPTION OF A WRIT BY THE LEGAL DEPARTMENT. THIS COMPLAINT COVERS THE REVITAN REVISION PERFORMED ON (B)(6) 2018 WHICH WAS MENTIONED IN THE LEGAL WRIT. WITHIN THE SUMMARY IT IS MENTIONED THAT THIS REVITAN REVISION WAS PERFORMED DUE TO STEM SINTERING. REVIEW OF RECEIVED DATA: IN TOTAL 18 X-RAYS WERE RECEIVED FOR REVIEW. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: ACCORDING TO THE PROVIDED DATA THE PATIENT WAS IMPLANTED WITH A REVITAN STEM ON (B)(6) 2018. ON THE THREE X-RAYS DATED (B)(6) 2018 A DISLOCATION IS VISIBLE. ON (B)(6) 2018 THE REVITAN STEM WAS REVISED TO ANOTHER REVITAN STEM DUE TO STEM SINTERING. TAKING INTO ACCOUNT THE PRESENT X-RAY DOCUMENTATION, NO IMPLANT-RELATED CAUSES FOR THE RECURRENT DISLOCATION OF THE LEFT HIP CAN BE IDENTIFIED. RADIOLOGICALLY CORRECT POSITION OF THE IMPLANTED REVITAN STEM AND CORRECT CUP POSITION WAS FOUND. HOWEVER, LATERALLY BONY SUPPORT IS MISSING OVER A DISTANCE OF TWO THIRDS OF THE HEIGHT OF THE PROXIMAL REVITAN COMPONENT AND DISTAL MEDIALLY A FRACTURE THROUGH THE CORTICALIS CAN BE SEEN. ON (B)(6) 2018 IN THE AREA OF THE DISTAL PROSTHESIS PART RECOGNIZABLE RADIOLUCENT LINE MEDIALLY AND LATERALLY OF THE STEM. BASED ON THE COMPARISON OF SPECIFIC LANDMARKS ON X-RAYS DATED (B)(6) 2018 AND X-RAY (B)(6) 2018, A SHIFT INTO DISTAL DIRECTION OF THE STEM CAN BE RECOGNIZED. MOST LIKELY, THE CHANGE IN POSITION OCCURRED DURING DISLOCATION. 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 AVAILABLE X-RAYS AND THE PATIENT ANAMNESIS, IT IS LIKELY THAT THE DISLOCATION LED TO THE SINTERING OF THE STEM. IN ADDITION, PATIENT FACTORS SUCH AS WEIGHT AND COMPLIANCE TO REHABILITATION PROTOCOL MAY HAVE NEGATIVELY INFLUENCED THE PERFORMANCE OF THE DEVICE. NEVERTHELESS, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00014, 0009613350-2019-00015.
IT WAS NOW REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO STEM SUBSIDENCE.
NO CHANGES TO EVENT DESCRIBTION.
NO EVENT UPDATE.
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
CONCOMITANT MEDICAL PRODUCTS ACCORDING MEDICAL DEVICES: NAME: UNKNOWN REVITAN PROXIMAL STEM HIP ITEM: UNKNOWN, LOT#: UNKNOWN. DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON (B)(6) 2019 TO THE APPROPRIATE REPRESENTATIVES: PRODUCT IDENTIFICATION, MEDICAL RECORDS, REASON FOR REVISION, MEDICAL IMAGING, PRODUCT AVAILABILITY FOR INVESTIGATION. 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). NOTE: THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT (SAME PATIENT) : (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2019 - 00015.
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27201 | REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/260 | UNKNOWN | LZO | ZIMMER GMBH | N/A | 2921641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | SEE H10 NARRATIVE| SEE H10 NARRATIVE| SEE H10 NARRATIVE |