FDA Adverse Event
Malfunction
Summary report: N
NEXGEN LPS-FLEX ARTICULAR SURFACE
MDR report key: 2093566
·
Received April 6, 2011
Report
- Report Number
- 1822565-2011-00866
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 10, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT WHEN OPENING THE PACKAGING, IT WAS APPARENT THAT THE SEAL WAS NOT PROPERLY GLUED DOWN. ANOTHER ARTICULAR SURFACE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS-FLEX ARTICULAR SURFACE | JWH | ZIMMER, INC. | 61597689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |