FDA Adverse Event
Injury
Summary report: N
NEXGEN LCCK ARTICULAR SURFACE
MDR report key: 2220292
·
Received August 16, 2011
Report
- Report Number
- 1822565-2011-01884
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 20, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED FOR A LOCKING SCREW THAT BACKED OUT OF THE ARTICULAR SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LCCK ARTICULAR SURFACE | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |