FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEXGEN ARTICULAR SURFACE
MDR report key: 4092248
·
Received August 20, 2014
Report
- Report Number
- 1822565-2014-01003
- Event Type
- Injury
- Date Received
- August 20, 2014
- Date of Event
- June 27, 2014
- Report Date
- July 23, 2014
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A USER FACILITY 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 PT WAS REVISED DUE TO INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500783 | UNKNOWN NEXGEN ARTICULAR SURFACE | KNEE PROSTHESIS | JWH | ZIMMER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |