FDA Adverse Event
Injury
Summary report: N
UNKNOWN KNEE
MDR report key: 3951157
·
Received July 22, 2014
Report
- Report Number
- 0001825034-2014-06306
- Event Type
- Injury
- Date Received
- July 22, 2014
- Report Date
- June 23, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PUNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427520 | UNKNOWN KNEE | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |