FDA Adverse Event
Malfunction
Summary report: N
MIS QUAD-SPARING FEMORAL INSERTER/EXTRACTOR
MDR report key: 2142153
·
Received May 26, 2011
Report
- Report Number
- 1822565-2011-01242
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 28, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: ONLY THE SUBCOMPONENT IMPACTOR PAD WAS RETURNED. IN GENERAL, IMPACTORS BECOME DAMAGED THROUGH REPEATED USE DUE TO IMPACTIONS SUSTAINED WHILE IN USE. IMPACTORS OR IMPACTOR HEADS SHOULD BE REPLACED WHEN THE PART IS NO LONGER FUNCTIONING. THE RETURNED DEVICE HAS EXCEEDED ITS USEFUL LIFE. EVALUATION: NO LOT NUMBER WAS PROVIDED. AS SUCH, MANUFACTURING DOCUMENTATION CANNOT BE REVIEWED AND POTENTIAL FIELD AGE CANNOT BE ASCERTAINED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE IMPACTION PAD HAS FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIS QUAD-SPARING FEMORAL INSERTER/EXTRACTOR | HWA | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |