FDA Adverse Event
Injury
Summary report: N
UNKNOWN AGC
MDR report key: 6146319
·
Received December 5, 2016
Report
- Report Number
- 0001825034-2016-05050
- Event Type
- Injury
- Date Received
- December 5, 2016
- Date of Event
- November 14, 2016
- Report Date
- May 26, 2017
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PNI
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PT AGE: - PATIENT WAS (B)(6) YEARS OLD AT THE TIME OF THE INITIAL PROCEDURE.
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
PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY 20 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 797317 | UNKNOWN AGC | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |