FDA Adverse Event
Injury
Summary report: N
OPTETRAK TIBIAL TRAY, FINNED, CEMENTED
MDR report key: 4973341
·
Received August 5, 2015
Report
- Report Number
- 1038671-2015-00411
- Event Type
- Injury
- Date Received
- August 5, 2015
- Date of Event
- September 17, 2014
- Report Date
- August 5, 2015
- 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
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.
Description of Event or Problem · 1
INDEX SURGERY: (B)(6) 2014. REVISION OF RIGHT KNEE COMPONENTS DUE TO INFECTION AND INFLAMMATORY REACTION OF PROSTHETIC DEVICES. A SPACER WAS LEFT IN. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514029 | OPTETRAK TIBIAL TRAY, FINNED, CEMENTED | TIBIAL TRAY | JWH | EXACTECH, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |