FDA Adverse Event
Malfunction
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA
MDR report key: 1220796
·
Received October 31, 2008
Report
- Report Number
- 1822565-2008-00755
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- September 25, 2008
- Report Date
- September 25, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THERE WERE NO PLASTIC BEADS FOUND ON THE PART AS REPORTED ON THE COMPLAINT. THE BACK SURFACE SHOWS CLEAR SURFACES WITH ALL THE MARKINGS CRISP, CLEAR AND PERFECTLY LEGIBLE. THE ONLY IRREGULARITY NOTED WAS THE MATERIAL CHIPPED AWAY FROM THE AREA NEAR THE ANTERIOR LOCKING NOTCH. THIS COULD HAVE BEEN CAUSED BY INSERTION/EXTRACTION. THE PROBLEM COULD NOT BE CONFIRMED. EVALUATION: DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGERY WAS DELAYED FOR AN UNKNOWN AMOUNT OF TIME AND THERE ARE SOME PLASTIC BEADS UNDER THE ARTICULAR SURFACE. THIS MADE THE ARTICULAR SURFACE ALLEGEDLY "NOT CLEAR". COULD NOT INSERT IN THE TIBIA TRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA | KNEE PROSTHESIS | JWH | ZIMMER, INC. | NA | 61013960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |