FDA Adverse Event
Malfunction
Summary report: N
NEXGEN LPS-FLEX ARTICULAR SURFACE
MDR report key: 2090212
·
Received April 11, 2011
Report
- Report Number
- 1822565-2011-00891
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- June 2, 2010
- Report Date
- June 8, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE TOP FOIL LAYER OF THE PACKAGING WAS NOT SEALED. ANOTHER DEVICE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS-FLEX ARTICULAR SURFACE | JWH | ZIMMER, INC. | 61387710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |