FDA Adverse Event
Injury
Summary report: N
OXFORD PARTIAL KNEE SYSTEM LEFT MEDIAL MENISCAL BEARING 3MM THICK
MDR report key: 6377368
·
Received March 3, 2017
Report
- Report Number
- 3002806535-2017-00109
- Event Type
- Injury
- Date Received
- March 3, 2017
- Date of Event
- January 18, 2017
- Report Date
- March 3, 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
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCOMITANT MEDICAL PRODUCTS ¿ OXFORD TWIN PEG FEMUR CATALOG 161469 LOT 864130; OXFORD TIBIAL TRAY CATALOG 154726 LOT 691750.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REVISION PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. THE TIBIAL BEARING WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158561 | OXFORD PARTIAL KNEE SYSTEM LEFT MEDIAL MENISCAL BEARING 3MM THICK | PROSTHESIS, KNEE | NRA | BIOMET UK LTD. | N/A | 521310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R |