FDA Adverse Event
Injury
Summary report: N
NEXGEN CR-FLEX FEMORAL COMPONENT
MDR report key: 2041217
·
Received March 30, 2011
Report
- Report Number
- 1822565-2011-00764
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 3, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
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 A CR FLEX FEMUR WAS MISTAKENLY USED WITH AN LPS ARTICULATING SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN CR-FLEX FEMORAL COMPONENT | JWH | ZIMMER, INC. | 61716749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other | NEXGEN LPS-FLEX ARTICULAR SURFACE| CATALOG #00596403210, LOT #UNK |