FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS-FLEX POLY ARTICULAR SURFACE
MDR report key: 1940555
·
Received December 21, 2010
Report
- Report Number
- 1822565-2010-01386
- Event Type
- Injury
- Date Received
- December 21, 2010
- Report Date
- December 9, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A CONSUMER 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 PT WAS EXPERIENCING PAIN, REQUIRING FLUID DRAINAGE AND SHOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS-FLEX POLY ARTICULAR SURFACE | KNEE PROSTHESIS | JWH | ZIMMER, INC. | 60660972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other | CATALOG # 00598603702, LOT # 60621737| POSTERIOR STABILIZED (LPS) FEMORAL COMPONENT:| CATALOG # 00599601452, LOT # 60555127| NEXGEN COMPLETE KNEE SOLUTION STEMMED| NEXGEN COMPLETE KNEE SOLUTION INSET ALL POLY| PATELLA: CATALOG # 00597206526, LOT # 60639630| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE -| NONAUGMENTABLE TIBIAL COMPONENT: |