FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS ARTICULAR SURFACE
MDR report key: 2172649
·
Received July 20, 2011
Report
- Report Number
- 1822565-2011-01668
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- July 27, 2009
- Report Date
- June 20, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED FOR AN UNK REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS ARTICULAR SURFACE | JWH | ZIMMER, INC. | 60003393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | MFG BY ZIMMER B.V. PONCE PUERTO RICO| MFG BY ZIMMER B.V. PONCE PUERTO RICO| CATALOG #00598605701, LOT #60094586| CATALOG #00599601602, LOT #60092816| NEXGEN LPS FEMORAL COMPONENT| CATALOG #00597206535, LOT #60101610| NEXGEN ALL POLY PATELLA| NEXGEN STEMMED TIBIAL COMPONENT |