FDA Adverse Event
Injury
Summary report: N
NEXGEN LCCK ARTICULAR SURFACE
MDR report key: 3031987
·
Received March 28, 2013
Report
- Report Number
- 1822565-2013-00554
- Event Type
- Injury
- Date Received
- March 28, 2013
- Date of Event
- February 26, 2013
- Report Date
- February 26, 2013
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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 PATIENT WAS REVISED DUE TO A FALL WHICH LOOSENED THE SCREW AND BROKE THE POLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128656 | NEXGEN LCCK ARTICULAR SURFACE | JWH | ZIMMER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |