FDA Adverse Event
Injury
Summary report: N
OXFORD PKS FEMORAL COCR MEDIUM
MDR report key: 2921748
·
Received January 18, 2013
Report
- Report Number
- 3002806535-2013-00006
- Event Type
- Injury
- Date Received
- January 18, 2013
- Date of Event
- December 18, 2012
- Report Date
- December 19, 2012
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- PP010014
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY OXFORD KNEE REVISION ON (B)(6) 2005. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PAIN WITH DISEASE PROGRESSION. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27993 | OXFORD PKS FEMORAL COCR MEDIUM | OXFORD FEMORAL KNEE | NRA | BIOMET UK LTD. | N/A | 861177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |