FDA Adverse Event
Malfunction
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR
MDR report key: 1011958
·
Received March 11, 2008
Report
- Report Number
- 1822565-2008-00089
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 18, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE STAIN IS MOST LIKELY DUE TO MOISTURE EXPOSURE POST PACKAGING. THE GAS PLASMA PROCESS WAS EVALUATED AND WOULD NOT PRODUCE THIS STAINING. THE PACKAGE SEAL IS COMPLETE AND IS IN EXCELLENT CONDITION. STERILE BARRIER INTEGRITY IS INTACT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT WHEN THE IMPLANT WAS OPENED, THE INNER STERILE PACKAGE HAD A STAIN ON THE LID WHERE THE PEEL HERE WRITING IS LOCATED. THE IMPLANT WAS NOT USED, AS STERILITY COULD NOT BE ASSURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR | KNEE PROSTHESIS | JWH | ZIMMER, INC. | NA | 60518927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |