FDA Adverse Event
Malfunction
Summary report: N
NEXGEN FEMORAL PROVISIONAL IMPACTOR/EXTRACT
MDR report key: 1931986
·
Received November 30, 2010
Report
- Report Number
- 1822565-2010-01236
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR 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 WHILE IMPACTING THE FEMORAL TRIAL WITH THE LOCKING IMPACTOR, A RETAINING CLIP BROKE AND THE INSTRUMENT BROKE INTO SEVERAL PIECES. AN X-RAY WAS ORDERED TO DETERMINE IF THE BROKEN PIECES WERE IN THE PATIENT. AFTER THE CASE, THE FINAL PIECE WAS FOUND ON THE FLOOR AND ALL MEMBERS OF THE SURGICAL TEAM WERE SATISFIED THAT ALL PARTS WERE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN FEMORAL PROVISIONAL IMPACTOR/EXTRACT | KNEE INSTRUMENT | JWH | ZIMMER, INC. | 61565681 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |