FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEXGEN CR-FLEX KNEE
MDR report key: 3954780
·
Received July 18, 2014
Report
- Report Number
- 1822565-2014-00887
- Event Type
- Injury
- Date Received
- July 18, 2014
- Date of Event
- February 26, 2010
- Report Date
- June 20, 2014
- 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 WAS REVISED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422538 | UNKNOWN NEXGEN CR-FLEX KNEE | KNEE PROSTHESIS | JWH | ZIMMER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |