FDA Adverse Event
Other
Summary report: N
PATELLA
MDR report key: 1843844
·
Received September 21, 2010
Report
- Report Number
- 1038671-2010-00137
- Event Type
- Other
- Date Received
- September 21, 2010
- Date of Event
- August 10, 2010
- Report Date
- September 21, 2010
- Manufacturer
- EXACTECH INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ENGINEERING EVAL OF THE RETURNED PATELLA NOTED THAT THE PEG HAD BEEN CUT OFF AND THERE WERE MARKS ON THE BACKSIDE CONSISTENT WITH A SAW BLADE BEING USED TO REMOVE THE DEVICE. THE ARTICULAR SURFACE OF THE DEVICE HAD OFF CENTER DEFORMATION WITH AN EDGE FORMING NEAR THE DEFORMATION.
Description of Event or Problem · 1
REVISION OF TOTAL KNEE ARTHROPLASTY DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATELLA | JWH | EXACTECH INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |