FDA Adverse Event
Injury
Summary report: N
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 LEFT MEDIAL TIBIAL TRAY STD SIZE D
MDR report key: 2110635
·
Received June 1, 2011
Report
- Report Number
- 1825034-2011-00462
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- December 8, 2010
- Report Date
- May 9, 2011
- Manufacturer
- BIOMET UK LTD
- Product Code
- NRA
- PMA / PMN Number
- P010014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT FILED (B)(6), 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, PATIENT REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 TO REMOVE THE PARTIAL KNEE COMPONENTS. DETAILED EVENT INFORMATION REGARDING THE REVISION WAS NOT PROVIDED. NO FURTHER INFORMATION HAS BEEN SUPPLIED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXFORD UNICOMPARTMENTAL KNEE PHASE 3 LEFT MEDIAL TIBIAL TRAY STD SIZE D | PROSTHESIS, KNEE | NRA | BIOMET UK LTD | N/A | 391732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| R |