FDA Adverse Event
Injury
Summary report: N
TGS UKA FEMORAL AND TIBIAL COMPONENTS
MDR report key: 2174961
·
Received July 21, 2011
Report
- Report Number
- 3004594167-2011-00008
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 13, 2011
- Report Date
- July 12, 2011
- Manufacturer
- ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
- Product Code
- HSX
- PMA / PMN Number
- K090024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG #: 100036, LOT #: 0910036, EXPIRATION DATE: 04/2010. ADD'L DEVICE MFR DATE: 04/2009. PRODUCT WAS NOT RETURNED FOR EVAL. 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 ADD'L INFO REC'D, THE INVESTIGATION MAY BE RE-OPENED.
Description of Event or Problem · 1
PT WAS CONVERTED TO A TOTAL KNEE DUE TO TIBIAL COLLAPSE LEADING TO LOOSENING OF THE TIBIAL COMPONENT. CONVERSION WAS UNEVENTFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TGS UKA FEMORAL AND TIBIAL COMPONENTS | UNICOMPARTMENTAL KNEE COMPONENT | HSX | ALEXANDRIA RESEARCH TECHNOLOGIES, LLC | 0909042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R |