FDA Adverse Event
Malfunction
Summary report: N
VERSYS FEMORAL HEAD
MDR report key: 3802448
·
Received February 21, 2014
Report
- Report Number
- 2648920-2014-00030
- Event Type
- Malfunction
- Date Received
- February 21, 2014
- Date of Event
- January 22, 2014
- Report Date
- January 23, 2014
- Manufacturer
- ZIMMER
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- 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 HEAD WOULD NOT MATE WITH THE TAPER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110392 | VERSYS FEMORAL HEAD | JDI | ZIMMER | 62508449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |