FDA Adverse Event
Injury
Summary report: N
NEXGEN CR-FLEX PRECOAT FEMORAL COMPONENT
MDR report key: 4112857
·
Received September 17, 2014
Report
- Report Number
- 1822565-2014-01144
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- November 12, 2013
- Report Date
- August 19, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION 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 PATIENT WAS REVISED DUE TO KNEE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577142 | NEXGEN CR-FLEX PRECOAT FEMORAL COMPONENT | JWH | ZIMMER, INC. | 61636339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |