FDA Adverse Event
Other
Summary report: N
THREE PEG PATELLA
MDR report key: 1781399
·
Received July 28, 2010
Report
- Report Number
- 1038671-2010-00097
- Event Type
- Other
- Date Received
- July 28, 2010
- Date of Event
- April 15, 2010
- Report Date
- July 28, 2010
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
REVISION OF KNEE ARTHROPLASTY 9 MONTHS POSTOPERATIVELY DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THREE PEG PATELLA | JWH | EXACTECH, INC. | 0888942 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |