FDA Adverse Event
Injury
Summary report: N
VANGUARD PS TIBIAL BEARING
MDR report key: 2092735
·
Received May 10, 2011
Report
- Report Number
- 3002806535-2011-00064
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- December 2, 2010
- Report Date
- April 11, 2011
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JWH
- PMA / PMN Number
- K023546
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS REC'D. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED (B)(4), 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2010. PT UNDERWENT REVISION SURGERY ON (B)(6), 2010 DUE TO INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VANGUARD PS TIBIAL BEARING | JWH | BIOMET UK LTD. | NA | 1803266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |