FDA Adverse Event
Malfunction
Summary report: N
MIS TOTAL KNEE FEMORAL INSERTER/EXTRACTOR
MDR report key: 2102851
·
Received April 12, 2011
Report
- Report Number
- 1822565-2011-01167
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- April 3, 2011
- Report Date
- April 15, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: BASED ON THE LOT NUMBER, THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROX 10 MONTHS AND HAS BEEN USED AN UNK NUMBER OF TIMES DURING THAT PERIOD. IN GENERAL, IMPACTORS BECOME DAMAGED THROUGH REPEATED USE DUE TO IMPACTIONS SUSTAINED WHILE IN USE. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. DIMENSIONS TAKEN ARE WITHIN SPEC AS RECORDED. NO MFG ABNORMALITIES COULD BE DETECTED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE FEMORAL IMPACTOR PAD FRACTURED DURING FEMORAL IMPACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIS TOTAL KNEE FEMORAL INSERTER/EXTRACTOR | HWA | ZIMMER, INC. | 61523502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |