FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER KNEE
MDR report key: 6144027
·
Received December 4, 2016
Report
- Report Number
- 0001822565-2016-04518
- Event Type
- Injury
- Date Received
- December 4, 2016
- Report Date
- December 2, 2016
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- PMA / PMN Number
- PNI
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- 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.
Description of Event or Problem · 1
PATIENT ALLEGED AUDIBLE NOISE, INSTABILITY OF THE JOINT, METAL ALLERGY AND RASH ONE YEAR POST IMPLANTATION. NO REVISION HAS BEEN REPORTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794523 | UNKNOWN ZIMMER KNEE | PROSTHESIS; KNEE | JWH | ZIMMER, INC. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |