FDA Adverse Event
Injury
Summary report: N
VERSA-FX STANDARD REAMER HEAD
MDR report key: 2041088
·
Received March 29, 2011
Report
- Report Number
- 1822565-2011-00779
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 1, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- HTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 WAS REPORTED THAT A FEMORAL NECK FRACTURE WAS BEING TREATED WITH A VERSAFX II PLATE AND SCREWS. IT WAS NOTED AFTER THE REAMER WAS WITHDRAWN THAT AN APPROX 5MM FRAGMENT OF CORTICAL BONE FROM THE LATERAL WALL OF THE FEMUR WAS BROKEN OFF BY THE OUTER TAPERED REAMER. THIS RESULTED IN A HOLE THAT WAS NOT CIRCULAR BUT OBLONG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSA-FX STANDARD REAMER HEAD | TRAUMA INSTRUMENT | HTO | ZIMMER INC | 55116100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |