OXF TWIN-PEG CMNTD FEM MD PMA
Report
- Report Number
- 3002806535-2021-00246
- Event Type
- Injury
- Date Received
- June 9, 2021
- Date of Event
- March 8, 2021
- Report Date
- August 11, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- UDI-DI
- 05019279438242
- PMA / PMN Number
- P010014
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: PATIENT¿S INFORMATION RECEIVED: PATIENT NAME: (B)(6). AGE: 60 YEARS. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 COMPLAINT REPORTED WITH THE ITEM 154723, 1 COMPLAINT REPORTED WITH THE ITEM 161469, AND (B)(4) COMPLAINTS REPORTED WITH THE ITEM 159575 (INCLUDING INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00245-2, 3002806535-2021-00247-2. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.
MYMOBILITY CLINICAL STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL PARTIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT EXPERIENCED PES BURSA WHICH ONSET ON (B)(6) 2021. THE SEVERITY WAS REPORTED AS MILD. TREATMENT: STEROID INJECTION. NOT DEVICE RELATED. POSSIBLY PROCEDURE RELATED. OUTCOME: TOLERATED.
MY MOBILITY CLINICAL STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL PARTIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT EXPERIENCED PES BURSA WHICH ONSET ON (B)(6) 2021. THE SEVERITY WAS REPORTED AS MILD. TREATMENT: STEROID INJECTION NOT DEVICE RELATED. POSSIBLY PROCEDURE RELATED.
(B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00245. 3002806535-2021-00247. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(6) CLINICAL STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL PARTIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, THE PATIENT EXPERIENCED PES BURSA WHICH ONSET ON (B)(6) 2021. THE SEVERITY WAS REPORTED AS MILD. TREATMENT: STEROID INJECTION. NOT DEVICE RELATED. POSSIBLY PROCEDURE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 860613 | OXF TWIN-PEG CMNTD FEM MD PMA | OXFORD CEMENTED FEMORALS | NRA | BIOMET UK LTD. | N/A | 649860 | 05019279438242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |