FDA Adverse Event
Other
Summary report: N
OPTETRAK
MDR report key: 1843845
·
Received September 21, 2010
Report
- Report Number
- 1038671-2010-00134
- 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 FEMORAL COMPONENT NOTED MARKINGS CONSISTENT WITH DEVICE REMOVAL AS WELL AS SEVERAL SMALL PIECES OF BONE AND SOFT TISSUE DEBRIS IN THE CEMENT POCKETS. SOFT TISSUE DEBRIS WAS ALSO EVIDENT ON THE ARTICULAR CAM AND IN THE INTERCONDYLAR BOX. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.
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 | OPTETRAK | HI-FLEX POSTERIOR STABELIZED FEMORAL | JWH | EXACTECH INC. | 0400201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |