FDA Adverse Event
Malfunction
Summary report: N
VERSYS HIP REVISION FEMORAL STEM
MDR report key: 2093291
·
Received May 3, 2011
Report
- Report Number
- 1822565-2011-01074
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- LPH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: BY VISUALLY EXAMINING THE RETURNED PACKAGING, IT APPEARS THAT THE PACKAGE WAS EXPOSED TO HAZARDS OUTSIDE THE NORMALLY ANTICIPATED DISTRIBUTION ENVIRONMENT. THE STEM MEETS PRINT SPECIFICATION WHERE MEASURED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 12MM HIP STEM WAS NOT USED DUE TO DAMAGE OF BOTH THE PLASTIC BAG HOLDING THE STEM AND THE FOAM INSERT. A 13MM STEM WAS IMPLANTED WITH DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSYS HIP REVISION FEMORAL STEM | LPH | ZIMMER, INC. | 74785300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |