FDA Adverse Event
Malfunction
Summary report: N
REVERSE GLENOSPHERE IMPACTOR HEAD
MDR report key: 2040393
·
Received February 15, 2011
Report
- Report Number
- 1822565-2011-00625
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 14, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: IT IS POSSIBLE THAT THE FRACTURE WAS DUE TO EXCESSIVE IMPACTION FORCE, BUT WITHOUT FURTHER INFO THIS CANNOT BE CONFIRMED. AS RETURNED, THE GLENOSPHERE IMPACTOR HEAD IS FRACTURED. BASED UPON THE LOT NUMBER, THE DEVICE HAD A POTENTIAL FIELD AGE OF APPROXIMATELY FOUR AND A HALF YEARS AT THE TIME OF FAILURE. MANUFACTURING DOCUMENTATION FOR THIS LOT HAS BEEN REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE GLENOSPHERE IMPACTOR HEAD FRACTURED DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVERSE GLENOSPHERE IMPACTOR HEAD | HWA | ZIMMER, INC. | 60514178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |