FDA Adverse Event
Malfunction
Summary report: N
NEXGEN FEMORAL PROVISIONAL IMPACTOR EXTRACT
MDR report key: 2081978
·
Received April 5, 2011
Report
- Report Number
- 1822565-2011-00862
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 8, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- MBH
- Removal / Correction Number
- 1822565-2/24/2011-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: SUBCOMPONENT GEOMETRY HAS BEEN IMPROVED TO STRENGTHEN THE DEVICE. FURTHERMORE, ALL DEVICES MFG PRIOR TO THE IMPLEMENTATION OF THIS CHANGE ARE BEING REMOVED FROM THE FIELD AS PART OF A REPORTABLE FIELD ACTION. REFERENCE 1822565-2/24/2011-001-R FOR ADD'L DETAILS. EVAL: SUBCOMPONENT SPRING CLIP FRACTURE IS REPORTED AND OBSERVED. DIMENSIONAL READINGS AND MATERIAL HARDNESS ARE CONFORMING TO PRINT SPECS.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SPRING CLIP FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN FEMORAL PROVISIONAL IMPACTOR EXTRACT | MBH | ZIMMER, INC. | 61610343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |