COBALT CHROME FEMORAL HEAD 5°42 Ø28 / 0 / 12-14/ COL MOYEN
Report
- Report Number
- 3006946279-2021-00214
- Event Type
- Injury
- Date Received
- December 29, 2021
- Date of Event
- December 15, 2021
- Report Date
- March 31, 2022
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- 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
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
(B)(4). D10 - LIST OF ASSOCIATED DEVICES: AVANTAGE INLAY S54 / 28, REFERENCE P0561054, BATCH 0001511683. UPTION COMP STEM L220 S4 D13 R, REFERENCE P0167413, BATCH 0001364370. AVANTAGE RELOAD CUP TI HA S54, REFERENCE P0460P54, BATCH 0001484128. UPTION COMP LOCKING PIN L.35MM, REFERENCE P0160035, BATCH 0001504673. UPTION COMP LOCKING PIN L.35MM, REFERENCE P0160035, BATCH 0001462952. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.
(B)(4), THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS RETURNED AND LAB ANALYSIS WAS PERFORMED. MEDICAL RECORDS WERE PROVIDED. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THIS DEVICE IS USED FOR TREATMENT. THE PRODUCTS INVOLVED IN THE COMPLAINT ARE COMPATIBLE. COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART/LOT COMBINATION. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. MEDICAL RECORDS WERE REVIEWED AND SHOW THAT PATIENT UNDERWENT A REVISION SURGERY ON (B)(6), 2021 FOLLOWING A PERIPROSTHETIC FRACTURE OF THE FEMUR. THEN, ON (B)(6), 2021, THE PATIENT UNDERWENT A MEDICAL INTERVENTION TO REDUCE A LUXATION OF THE PROSTHESIS. FINALLY, PATIENT WAS REVISED ON (B)(6), 2021, PATIENT SUFFERED FROM PAIN AND IT WAS NOTICED THAT THE PROSTHESIS DISLOCATED, THAT LED TO A REVISION SURGERY ON (B)(6), 2021. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO FURTHER ACTIONS HAVE BEEN INITIATED AS A RESULT OF THE REPORTED EVENT INVESTIGATION.
(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). LIST OF ASSOCIATED DEVICES: AVANTAGE INLAY S54 / 28, REFERENCE P0561054, BATCH 000151683. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.
IT WAS REPORTED THAT, A PATIENT UNDERWENT A REVISION SURGERY DUE TO INTRAPROSTHETIC DISLOCATION OF THE RIGHT TOTAL HIP PROSTHESIS.
IT WAS REPORTED THAT: A PATIENT UNDERWENT A REVISION SURGERY DUE TO INTRAPROSTHETIC DISLOCATION OF THE RIGHT TOTAL HIP PROSTHESIS.
IT WAS REPORTED, THAT THERE WAS AN INTRAPROSTHETIC DISLOCATION OF THE RIGHT TOTAL HIP PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2003575 | COBALT CHROME FEMORAL HEAD 5°42 Ø28 / 0 / 12-14/ COL MOYEN | METALLIC FEMORAL HEAD PROSTHESIS | KWA | BIOMET FRANCE S.A.R.L. | J6787299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Unknown | Required Intervention | ASSOCIATED DEVICE MENTIONED IN H10.| ASSOCIATED DEVICES LISTED IN H10. |