FDA Adverse Event
Injury
Summary report: N
OXFORD MENISCAL BEARING COMPONENT
MDR report key: 6216530
·
Received December 30, 2016
Report
- Report Number
- 3002806535-2016-00937
- Event Type
- Injury
- Date Received
- December 30, 2016
- Date of Event
- November 22, 2016
- Report Date
- December 30, 2016
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- PP010014
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. UNIQUE IDENTIFIER (UDI) # - (B)(4). MEDICAL PRODUCT - PN: 161470 LN: 166350 OXFORD FEMORAL COMPONENT, PN: 154727 LN: 1807863 OXFORD TIBIAL TRAY.
Description of Event or Problem · 1
PATIENT UNDERWENT A RIGHT KNEE REVISION AND IRRIGATION AND DEBRIDEMENT PROCEDURE SIX DAYS POST-IMPLANTATION DUE TO AN UNKNOWN REASON. THE POLYETHYLENE TIBIAL BEARING WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865751 | OXFORD MENISCAL BEARING COMPONENT | PROSTHESIS, KNEE | NRA | BIOMET UK LTD. | N/A | 688780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |