FDA Adverse Event
Injury
Summary report: N
NEXGEN LCCK ARTICULAR SURFACE
MDR report key: 2120067
·
Received June 7, 2011
Report
- Report Number
- 1822565-2011-01333
- Event Type
- Injury
- Date Received
- June 7, 2011
- Report Date
- May 10, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE CONNECTION PIN HAS BROKEN AND THAT REVISION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LCCK ARTICULAR SURFACE | JWH | ZIMMER, INC. | 60612020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |