FDA Adverse Event
Death
Summary report: N
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 MENISCAL BEARING LARGE RIGHT 3MM THICK
MDR report key: 6301496
·
Received February 3, 2017
Report
- Report Number
- 3002806535-2017-00060
- Event Type
- Death
- Date Received
- February 3, 2017
- Date of Event
- September 29, 2016
- Report Date
- February 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
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UDI# (B)(4). OXFORD LARGE FEMORAL CATALOG 154602 LOT 1382562; OXFORD TIBIAL TRAY SIZE D CATALOG 154725 LOT 1276295.
Description of Event or Problem · 1
A PATIENT ENROLLED IN A CLINICAL STUDY EXPIRED DUE TO INJURIES CAUSED BY A FALL APPROXIMATELY NINE YEARS POST IMPLANTATION; THE CAUSE OF THE FALL IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84427 | OXFORD UNICOMPARTMENTAL KNEE PHASE 3 MENISCAL BEARING LARGE RIGHT 3MM THICK | PROSTHESIS, KNEE | NRA | BIOMET UK LTD. | N/A | 1310716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death |