FDA Adverse Event
Injury
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYL
MDR report key: 680619
·
Received February 28, 2006
Report
- Report Number
- 1822565-2006-00051
- Event Type
- Injury
- Date Received
- February 28, 2006
- Date of Event
- January 18, 2006
- Report Date
- February 6, 2006
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED IN 2003. THE LOCKING SCREW BROKE AND WAS FLOATING FREELY IN THE JOINT. THE DEVICE WAS REVISED ON JANUARY 18, 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYL | KNEE PROSTHESIS | JWH | ZIMMER, INC. | NA | 55387800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |