FDA Adverse Event
Injury
Summary report: N
OXFORD TIBIAL BEARING
MDR report key: 1940506
·
Received December 21, 2010
Report
- Report Number
- 3002806535-2010-00105
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 24, 2010
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- P010014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT WAS FILED (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE ON (B)(6), 2004. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO BEARING DISLOCATION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXFORD TIBIAL BEARING | NRA | BIOMET UK LTD. | NA | 704760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |