OXF UNI TIB TRAY SZ AA LM PMA
Report
- Report Number
- 3002806535-2022-00516
- Event Type
- Injury
- Date Received
- December 28, 2022
- Date of Event
- December 6, 2022
- Report Date
- January 27, 2023
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- P010014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF ANAT BRG LT SM, SIZE 4, PMA, ITEM#: 159541, LOT#: 811030, OXF TWIN-PEG CMNTD FEM SM, PMA, ITEM#: 161468, LOT#: 947260. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2022-00514, 3002806535-2022-00515. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO TIBIAL SUBSIDENCE APPROXIMATELY EIGHT (8) MONTHS AFTER INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN REASONS, APPROXIMATELY EIGHT (8) MONTHS AFTER INITIAL SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2093600 | OXF UNI TIB TRAY SZ AA LM PMA | KNEE PROTHESIS | NRA | BIOMET UK LTD. | N/A | 297320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Prefer Not To Disclose | Hospitalization| R | SEEH10NARRATIVE |