FDA Adverse Event
Injury
Summary report: N
OXF ANAT BRG LT SM SIZE 3 PMA
MDR report key: 6230838
·
Received January 6, 2017
Report
- Report Number
- 3002806535-2017-00016
- Event Type
- Injury
- Date Received
- January 6, 2017
- Date of Event
- November 10, 2016
- Report Date
- January 6, 2017
- 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
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). CONCOMITANT PRODUCTS¿ OXFORD TIBIAL TRAY SIZE CATALOG 157720, LOT 177450; OXFORD FEMORAL SMALL, CATALOG 161468, LOT 221500.
Description of Event or Problem · 1
PATIENT UNDERWENT A REVISION FROM A PARTIAL TO A TOTAL LEFT KNEE PROSTHESIS APPROXIMATELY SIX MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11621 | OXF ANAT BRG LT SM SIZE 3 PMA | PROSTHESIS, KNEE | NRA | BIOMET UK LTD. | N/A | 763820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |