FDA Adverse Event
Malfunction
Summary report: N
NEXGEN FEMORAL IMPACTOR/EXTRACTOR
MDR report key: 2013289
·
Received March 8, 2011
Report
- Report Number
- 1822565-2011-00498
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 7, 2011
- 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
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PIECE OF METAL WAS DETECTED IN THE KNEE WHILE THE SURGEON WAS REMOVING EXCESS BONE CEMENT. THE PIECE OF METAL WAS REMOVED AND IDENTIFIED AS PORTION OF THE CLIP FROM THE IMPACTOR/EXTRACTOR USED DURING SURGERY. IT WAS REPORTED THAT ALL PIECES WERE REMOVED FROM THE WOUND SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN FEMORAL IMPACTOR/EXTRACTOR | JWH | ZIMMER, INC. | 61542077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |