FDA Adverse Event
Injury
Summary report: N
OXF ANATOMIC BRG RT SM SIZE 4
MDR report key: 3091252
·
Received May 3, 2013
Report
- Report Number
- 0001825034-2013-01243
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 3, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- NRA
- PMA / PMN Number
- PP010014
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 OR DEVIATION.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT PARTIAL KNEE PROCEDURE (B)(6) 2009. A SUBSEQUENT REVISION TO A TOTAL KNEE WAS PERFORMED (B)(6) 2013, DUE TO INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194255 | OXF ANATOMIC BRG RT SM SIZE 4 | PROSTHESIS, KNEE | NRA | BIOMET ORTHOPEDICS | N/A | 1431534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |