FDA Adverse Event
Injury
Summary report: N
NEXGEN LCCK ART SURFACE WITH LOCKING SCREW
MDR report key: 2141042
·
Received June 21, 2011
Report
- Report Number
- 1822565-2011-01447
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- January 15, 2011
- Report Date
- May 25, 2011
- Manufacturer
- ZIMMER INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 LOOSENING OF THE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LCCK ART SURFACE WITH LOCKING SCREW | JWH | ZIMMER INC. | 52832000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |