BIOLOX D MOD CER HD 32MM STD
Report
- Report Number
- 3002806535-2020-00359
- Event Type
- Injury
- Date Received
- August 4, 2020
- Date of Event
- July 16, 2019
- Report Date
- January 5, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FINAL / FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: INFORMATION HAS BEEN RECEIVED FROM OUR LEGAL DEPARTMENT PROVIDING ADDITIONAL PATIENT DETAILS: HEIGHT: 5.8, WEIGHT: 78 KGS, ACTIVITY LEVEL: ABOVE AVERAGE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. RADIOGRAPHS RECEIVED: FOUR RADIOGRAPHS WERE PROVIDED WITH (B)(4) FOR ANALYSIS: ONE PRE-REVISION ANTEROPOSTERIOR (AP) RADIOGRAPH ((B)(6) 2019), ONE POST-REVISION AP RADIOGRAPH ((B)(6) 2019), ONE POST-REVISION LATERAL RADIOGRAPH ((B)(6) 2019) AND ONE POST-REVISION AP RADIOGRAPH TAKEN ON AN UNKNOWN DATE. THE (B)(4) IS ASSOCIATED WITH THE FRACTURE OF THE BIOLOX DELTA FEMORAL HEAD. THEREFORE, ONLY THE PRE-REVISION AP RADIOGRAPH IS ANALYSED IN THIS REPORT. AT THE TIME OF WRITING THIS ACTION ITEM, POST-PRIMARY RADIOGRAPHS HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED FOR ANALYSIS. POST-PRIMARY RADIOGRAPHS ARE REQUIRED IN ORDER TO ASSESS THE INITIAL COMPONENT SIZING, POSITIONING AND ALIGNMENT. THE PRE-REVISION AP RADIOGRAPH SHOWS THAT THE BIOLOX DELTA FEMORAL HEAD HAS FRACTURED INTO MULTIPLE FRAGMENTS. THE REVISED FRAGMENTS HAVE NOT BEEN RECEIVED FOR EXAMINATION. THE INCLINATION ANGLE OF THE ACETABULAR SHELL IN THE PRE-REVISION AP RADIOGRAPH IS APPROXIMATELY 45 DEGREES (MEASURED WITH IMAGEJ V1.52N, NIH, USA), WHICH IS COMPARABLE TO THE 40° TO 45° SURGICAL INCLINATION ANGLE RECOMMENDED IN THE EXCEED ABT OPERATIVE TECHNIQUE. THE MANUFACTURING HISTORY RECORDS FOR THE BIOLOX DELTA FEMORAL HEAD HAVE BEEN CHECKED AND VERIFY THAT THE COMPONENT WAS MANUFACTURED AND STERILIZED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE INSTRUCTIONS FOR USE PROVIDED WITH THE BIOLOX DELTA FEMORAL HEAD PROVIDED THE FOLLOWING INFORMATION: WARNINGS AND PRECAUTIONS: 4. MALALIGNMENT OF COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE. 6. IMPROPER PREOPERATIVE OR INTRA-OPERATIVE IMPLANT HANDLING OR DAMAGE (SCRATCHES, DENTS, ETC.) CAN LEAD TO CREVICE CORROSION, FRETTING, FATIGUE FRACTURE, AND/OR EXCESSIVE WEAR. 15. DO NOT USE ANY COMPONENT THAT IS NICKED, SCRATCHED, CHIPPED OR OTHERWISE ALTERED. 17. ALL MODULAR COMPONENTS MUST BE ACCURATELY SEATED TO PREVENT DISASSOCIATION. 19. DO NOT USE CERAMIC COMPONENTS THAT HAVE BEEN DROPPED, RUBBED, SCRATCHED, OR DISFIGURED. BLEMISHES OF ANY NATURE MAY BE EXPECTED TO CAUSE FAILURE. 20. ONCE CERAMIC COMPONENTS HAVE BEEN SEATED DO NOT REMOVE AND REUSE. 22. FIRMLY SEAT MODULAR HEAD COMPONENTS TO PREVENT DISSOCIATION AND/OR MICRO MOTION. MICRO MOTION MAY CONTRIBUTE TO DIFFICULT HEAD REMOVAL. 23. THOROUGHLY CLEAN AND DRY TAPER PRIOR TO ATTACHMENT OF THE MODULAR HEAD COMPONENT TO AVOID CREVICE CORROSION AND IMPROPER SEATING. 28. PATIENTS SHOULD BE WARNED OF THE IMPACT OF EXCESSIVE LOADING THAT CAN RESULT IF THE PATIENT IS INVOLVED IN AN OCCUPATION THAT INCLUDES SUBSTANTIAL WALKING, RUNNING, LIFTING, OR EXCESSIVE MUSCLE LOADING DUE TO WEIGHT THAT PLACE EXTREME DEMANDS ON THE HIP AND CAN RESULT IN DEVICE FAILURE OR DISLOCATION. THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) PROVIDED WITH THE COMPLAINT DOES NOT MENTION ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE ROOT CAUSE OF THE BIOLOX DELTA FEMORAL HEAD FRACTURE CANNOT BE ESTABLISHED WITHOUT FURTHER INFORMATION SUCH AS POST-PRIMARY RADIOGRAPHS, SURGICAL NOTES, EXAMINATION OF THE REVISED COMPONENTS AND FURTHER PATIENT INFORMATION. RISK ASSESSMENT: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLE COULD NOT BE SELECTED FOR COMPARISON. THE EVENT REPORTS REVISION DUE TO IMPLANT FRACTURE. THIS EVENT HAS A SEVERITY SCORE OF 3 WHICH IS DEFINED IN THE RMR AS: PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THEREFORE, THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS IN LINE WITH THE RMF. IN ORDER TO CALCULATE THE OCCURRENCE RATE, SALES AND COMPLAINT DATA FOR THIS ITEM NUMBER HAVE BEEN OBTAINED, AND ARE ATTACHED FOR A PERIOD OF THE LAST 3 YEARS PRIOR TO THE NOTIFICATION DATE, BEING JULY 2020. - SALES (JULY 2017 TO JULY 2020) = 11 UNITS. - COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN JULY 2017 TO JULY 2020 FOR ITEM (B)(4). - 2 COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER INCLUDING (B)(6). - THEREFORE, THE CALCULATED OCCURRENCE RATE IS 2 IN 11 OR 18.1%. - SINCE THE OCCURRENCE CALCULATION IS BASED ON ONLY 11 ITEM SALES, THE CURRENT OCCURRENCE RATINGS IN THE RISK MANAGEMENT FILE ARE STILL RELEVANT AND HAVE NOT BEEN EXCEEDED; AS IT IS NOT POSSIBLE TO MAKE A MEANINGFUL CALCULATION BASED ON 11 ITEM SALES. THE FAILURE MODE WILL BE MONITORED THROUGH ZIMMER BIOMET INTERNAL COMPLAINT AND POST MARKET SURVEILLANCE ACTIVITIES WITH FURTHER REVIEW OF RISK CONDUCTED THROUGH THESE PROCESSES. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.
(B)(4). THIS FINAL / FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND MAKE CORRECTIONS. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. RADIOGRAPHS RECEIVED: FOUR RADIOGRAPHS WERE PROVIDED WITH (B)(4) FOR ANALYSIS: ONE PRE-REVISION ANTEROPOSTERIOR (AP) RADIOGRAPH ((B)(6) 2019), ONE POST-REVISION AP RADIOGRAPH ((B)(6) 2019), ONE POST-REVISION LATERAL RADIOGRAPH ((B)(6) 2019) AND ONE POST-REVISION AP RADIOGRAPH TAKEN ON AN UNKNOWN DATE. THE (B)(4) IS ASSOCIATED WITH THE FRACTURE OF THE BIOLOX DELTA FEMORAL HEAD. THEREFORE, ONLY THE PRE-REVISION AP RADIOGRAPH IS ANALYSED IN THIS REPORT. THE PRE-REVISION AP RADIOGRAPH SHOWS THAT THE BIOLOX DELTA FEMORAL HEAD HAS FRACTURED INTO MULTIPLE FRAGMENTS. THE REVISED FRAGMENTS HAVE NOT BEEN RECEIVED FOR EXAMINATION. THE INCLINATION ANGLE OF THE ACETABULAR SHELL IN THE PRE-REVISION AP RADIOGRAPH IS APPROXIMATELY 45 DEGREES, WHICH IS COMPARABLE TO THE 40° TO 45° SURGICAL INCLINATION ANGLE RECOMMENDED IN THE EXCEED ABT OPERATIVE TECHNIQUE. THE MANUFACTURING HISTORY RECORDS FOR THE BIOLOX DELTA FEMORAL HEAD HAVE BEEN CHECKED AND VERIFY THAT THE COMPONENT WAS MANUFACTURED AND STERILIZED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. THE INSTRUCTIONS FOR USE PROVIDED WITH THE BIOLOX DELTA FEMORAL HEAD PROVIDED THE FOLLOWING INFORMATION: WARNINGS AND PRECAUTIONS: MALALIGNMENT OF COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE. IMPROPER PREOPERATIVE OR INTRA-OPERATIVE IMPLANT HANDLING OR DAMAGE (SCRATCHES, DENTS, ETC.) CAN LEAD TO CREVICE CORROSION, FRETTING, FATIGUE FRACTURE, AND/OR EXCESSIVE WEAR. DO NOT USE ANY COMPONENT THAT IS NICKED, SCRATCHED, CHIPPED OR OTHERWISE ALTERED. ALL MODULAR COMPONENTS MUST BE ACCURATELY SEATED TO PREVENT DISASSOCIATION. DO NOT USE CERAMIC COMPONENTS THAT HAVE BEEN DROPPED, RUBBED, SCRATCHED, OR DISFIGURED. BLEMISHES OF ANY NATURE MAY BE EXPECTED TO CAUSE FAILURE. ONCE CERAMIC COMPONENTS HAVE BEEN SEATED DO NOT REMOVE AND REUSE. FIRMLY SEAT MODULAR HEAD COMPONENTS TO PREVENT DISSOCIATION AND/OR MICRO MOTION. MICRO MOTION MAY CONTRIBUTE TO DIFFICULT HEAD REMOVAL. THOROUGHLY CLEAN AND DRY TAPER PRIOR TO ATTACHMENT OF THE MODULAR HEAD COMPONENT TO AVOID CREVICE CORROSION AND IMPROPER SEATING. PATIENTS SHOULD BE WARNED OF THE IMPACT OF EXCESSIVE LOADING THAT CAN RESULT IF THE PATIENT IS INVOLVED IN AN OCCUPATION THAT INCLUDES SUBSTANTIAL WALKING, RUNNING, LIFTING, OR EXCESSIVE MUSCLE LOADING DUE TO WEIGHT THAT PLACE EXTREME DEMANDS ON THE HIP AND CAN RESULT IN DEVICE FAILURE OR DISLOCATION. THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) PROVIDED WITH THE COMPLAINT DOES NOT MENTION ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT. THE ROOT CAUSE OF THE BIOLOX DELTA FEMORAL HEAD FRACTURE CANNOT BE ESTABLISHED WITHOUT FURTHER INFORMATION SUCH AS POST-PRIMARY RADIOGRAPHS, SURGICAL NOTES, EXAMINATION OF THE REVISED COMPONENTS AND FURTHER PATIENT INFORMATION. RISK ASSESSMENT: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLE COULD NOT BE SELECTED FOR COMPARISON. THE EVENT REPORTS REVISION DUE TO IMPLANT FRACTURE. THIS EVENT HAS A SEVERITY SCORE OF 3 WHICH IS DEFINED IN THE RMR AS: PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THEREFORE, THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS IN LINE WITH THE RMF. IN ORDER TO CALCULATE THE OCCURRENCE RATE, SALES AND COMPLAINT DATA FOR THIS ITEM NUMBER HAVE BEEN OBTAINED, AND ARE ATTACHED FOR A PERIOD OF THE LAST 3 YEARS PRIOR TO THE NOTIFICATION DATE, BEING JULY 2020. SALES (JULY 2017 TO JULY 2020) = (B)(4) UNITS. COMPLAINTS SEARCH WAS CONDUCTED FOR EVENTS OCCURRING BETWEEN (B)(6) 2017 TO JULY (B)(6) 2020 FOR ITEM (B)(4). 2 COMPLAINTS WERE IDENTIFIED FOR THIS ITEM NUMBER INCLUDING (B)(4). THEREFORE, THE CALCULATED OCCURRENCE RATE IS (B)(4). SINCE THE OCCURRENCE CALCULATION IS BASED ON ONLY (B)(4) ITEM SALES, THE CURRENT OCCURRENCE RATINGS IN THE RISK MANAGEMENT FILE ARE STILL RELEVANT AND HAVE NOT BEEN EXCEEDED; AS IT IS NOT POSSIBLE TO MAKE A MEANINGFUL CALCULATION BASED ON (B)(4) ITEM SALES. THE ALLEGED FAILURE MODE WILL BE MONITORED THROUGH ZIMMER. BIOMET INTERNAL COMPLAINT AND POST MARKET SURVEILLANCE ACTIVITIES WITH FURTHER REVIEW OF RISK CONDUCTED THROUGH THESE PROCESSES. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO CERAMIC HEAD FRACTURE WAS PERFORMED ON (B)(6) 2019. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO CERAMIC HEAD FRACTURE WAS PERFORMED ON (B)(6) 2019.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO CERAMIC HEAD FRACTURE WAS PERFORMED ON (B)(6) 2019. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.
(B)(4). FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: RINGLOC-X E1 H/W 52/32MM, CATALOG #: EP-053252, LOT #: 2781515. MEDICAL PRODUCT: EXC ABT RNGLC-X SHL HA/PC 052M, CATALOG #: 131352HA, LOT #: 2828936. MEDICAL PRODUCT: HA TAPERLOC POR FMRL 7.5X135, CATALOG #: 21-103202, LOT #: 2826922. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO CERAMIC HEAD FRACTURE WAS PERFORMED ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 825054 | BIOLOX D MOD CER HD 32MM STD | CERAMIC FEMORAL HEAD PROSTHESIS | LPH | BIOMET UK LTD. | N/A | 2932083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |