FDA Adverse Event
Injury
Summary report: N
NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE
MDR report key: 2860485
·
Received December 5, 2012
Report
- Report Number
- 1822565-2012-02475
- Event Type
- Injury
- Date Received
- December 5, 2012
- Date of Event
- November 18, 2010
- Report Date
- November 6, 2012
- 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 PATIENT HAD A MANIPULATION UNDER ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE | JWH | ZIMMER, INC. | 60783239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | MANUFACTURED BY ZIMMER (B)(4)| NEXGEN ALL POLY PATELLA| CATALOG #00597002502, LOT #60917547| CATALOG #00575001606, LOT #61174949| NEXGEN CR-FLEX GSF FEMORAL COMPONENT| NEXGEN CRUCIATE RETAINING TIBIAL COMPONENT| CATALOG #00597206535, LOT #61169305 |