FDA Adverse Event
Injury
Summary report: N
OXFORD UNICOMPARTMENTAL PHASE 3 FEMORAL COMPONENT
MDR report key: 2073145
·
Received April 29, 2011
Report
- Report Number
- 1825034-2011-00321
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- March 25, 2008
- Report Date
- March 31, 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
REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT FILED (B)(4), 2011.
Additional Manufacturer Narrative · 1
DATE IMPLANTED: UNKNOWN. THIS REPORT FILED APRIL 29, 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY AS PART OF A CLINICAL STUDY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT SUFFERED A GROUND LEVEL FALL DURING HOSPITAL STAY AND DISLOCATED HER MENISCAL BEARING. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 TO REMOVE AND REPLACE THE FEMORAL COMPONENT, TIBIAL TRAY AND TIBIAL BEARING. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXFORD UNICOMPARTMENTAL PHASE 3 FEMORAL COMPONENT | PROSTHESIS, KNEE | NRA | BIOMET UK LTD | N/A | 447786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R |