FDA Adverse Event
Injury
Summary report: N
VERSYS FEMORAL HEAD
MDR report key: 2932178
·
Received January 25, 2013
Report
- Report Number
- 1822565-2013-00182
- Event Type
- Injury
- Date Received
- January 25, 2013
- Date of Event
- December 27, 2012
- Report Date
- December 27, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 PATIENT WAS REVISED DUE TO LOOSENING, OSTEOLYSIS, PAIN AND TRUNNION WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36311 | VERSYS FEMORAL HEAD | LPH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |