FDA Adverse Event
Injury
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTIC
MDR report key: 1030040
·
Received April 15, 2008
Report
- Report Number
- 1822565-2008-00175
- Event Type
- Injury
- Date Received
- April 15, 2008
- Date of Event
- January 21, 2008
- Report Date
- January 31, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 DEVICE WAS REVISED IN 2008, DUE TO BROKEN POLY POST. THE IMPLANT DATE IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTIC | KNEE PROSTHESIS | JWH | ZIMMER, INC. | NA | 60630915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |