FDA Adverse Event
Injury
Summary report: N
TGS UKA FEMORAL COMPONENTS
MDR report key: 2509528
·
Received March 29, 2012
Report
- Report Number
- 3004594167-2012-00005
- Event Type
- Injury
- Date Received
- March 29, 2012
- Date of Event
- February 21, 2012
- Report Date
- March 20, 2012
- Manufacturer
- ALEXANDRIA RESEARCH TECHNOLOGIES, INC.
- Product Code
- HSX
- PMA / PMN Number
- K090024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS NOT RETURNED FOR EVALUATION. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ALEXANDRIA RESEARCH TECHNOLOGIES CONSIDERS THE INVESTIGATION OF THIS EVENT CLOSED AT THIS TIME. SHOULD THE PRODUCT BE RETURNED OR ADDITIONAL INFO RECEIVED, THE INVESTIGATION MAY BE RE-OPENED.
Description of Event or Problem · 1
PT WAS CONVERTED TO A TOTAL KNEE DUE TO PERSISTENT PAIN. CONVERSION WAS UNEVENTFUL. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TGS UKA FEMORAL COMPONENTS | UNICOMPARTMENTAL KNEE COMPONENT | HSX | ALEXANDRIA RESEARCH TECHNOLOGIES, INC. | F 1004012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R |