FDA Adverse Event
Injury
Summary report: N
UNKNOWN FEMORAL COMPONENT
MDR report key: 3092413
·
Received May 3, 2013
Report
- Report Number
- 0001825034-2013-01265
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 8, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PUNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT A KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO FEMORAL LOOSENING. THE PATIENT WAS REVISED USING A BIOMET SSK REVISION KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195281 | UNKNOWN FEMORAL COMPONENT | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |