FDA Adverse Event
Other
Summary report: N
PS TIBIAL INSERT
MDR report key: 1781378
·
Received July 28, 2010
Report
- Report Number
- 1038671-2010-00108
- Event Type
- Other
- Date Received
- July 28, 2010
- Date of Event
- January 27, 2009
- 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 MFR FOR EVAL.
Description of Event or Problem · 1
REVISION OF TOTAL KNEE ARTHROPLASTY 17 MONTHS POSTOPERATIVELY DUE TO LOOSENING OF TIBIAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PS TIBIAL INSERT | JWH | EXACTECH, INC. | 0945622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |