FDA Adverse Event
Injury
Summary report: N
OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING RIGHT MEDIAL LARGE SIZE 4MM
MDR report key: 6257661
·
Received January 17, 2017
Report
- Report Number
- 3002806535-2017-00031
- Event Type
- Injury
- Date Received
- January 17, 2017
- Date of Event
- December 19, 2016
- Report Date
- January 17, 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
UDI# - (B)(4). CONCOMITANT PRODUCT(S): -OXFORD PARTIAL KNEE SYSTEM RIGHT MEDIAL TIBIAL TRAY SIZE C CATALOG 154723 LOT 483150; OXFORD PARTIAL KNEE SYSTEM TWIN PEG FEMORAL CATALOG 161470 LOT 592540. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 3002806535-2017-00029 / 3002806535-2017-00031).
Description of Event or Problem · 1
PATIENT UNDERWENT A REVISION OF A PARTIAL KNEE APPROXIMATELY FIVE WEEKS POST IMPLANTATION DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39486 | OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING RIGHT MEDIAL LARGE SIZE 4MM | PROSTHESIS, KNEE | NRA | BIOMET UK LTD. | N/A | 228280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |