FDA Adverse Event
Malfunction
Summary report: N
NEXGEN FEMORAL AND PROV. IMPACTOR/EXTRACTOR
MDR report key: 2052153
·
Received March 1, 2011
Report
- Report Number
- 1822565-2011-00464
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- January 25, 2011
- Report Date
- January 31, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- MBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
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 WHILE INSERTING THE PROVISIONAL FEMORAL COMPONENT, THE INSTRUMENT'S SPRING CLIP BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN FEMORAL AND PROV. IMPACTOR/EXTRACTOR | MBH | ZIMMER, INC. | 61584069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |