FDA Adverse Event
Injury
Summary report: N
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 LEFT MEDIAL TIB TRAY STD SIZE E
MDR report key: 2111992
·
Received June 2, 2011
Report
- Report Number
- 1825034-2011-00465
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- August 2, 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
- VA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "PERSISTENT PAIN." (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO CONSTANT PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXFORD UNICOMPARTMENTAL KNEE PHASE 3 LEFT MEDIAL TIB TRAY STD SIZE E | PROSTHESIS, KNEE | NRA | BIOMET UK LTD | N/A | 235983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |