FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS-FLEX ARTICULAR SURFACE
MDR report key: 1940556
·
Received December 21, 2010
Report
- Report Number
- 1822565-2010-01429
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 3, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A DISTRIBUTOR 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 THE DEVICE WAS IMPLANTED IN (B)(6) 2009 AND THAT THE PT WAS REVISED FOR PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS-FLEX ARTICULAR SURFACE | KNEE PROSTHESIS | JWH | ZIMMER, INC. | 60969104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |