FDA Adverse Event
Injury
Summary report: N
TGS UKA FEMORAL COMPONENTS
MDR report key: 2460652
·
Received February 17, 2012
Report
- Report Number
- 3004594167-2012-00002
- Event Type
- Injury
- Date Received
- February 17, 2012
- Date of Event
- January 12, 2012
- Report Date
- February 9, 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
CONVERSION SURGERY WAS SCHEDULED DUE TO PERSISTENT PAIN. PT'S FEMORAL COMPONENT WAS FOUND TO BE LOOSE AND WAS CONVERTED TO A BI-COMPARTMENTAL FEMORAL COMPONENT. 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 1004011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |