FDA Adverse Event
Injury
Summary report: N
TGS UKA FEMORAL COMPONENT
MDR report key: 2227427
·
Received August 18, 2011
Report
- Report Number
- 3004594167-2011-00010
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- July 22, 2011
- Report Date
- August 19, 2011
- Manufacturer
- ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
- 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
SURGEON INDICATED THAT A TGS UKA FEMORAL COMPONENT HAD BEEN CONVERTED TO A BICOMPARTMENTAL FEMORAL COMPONENT AND A PATELLAR ARTHROPLASTY ON (B)(6) 2011 FOR PERSISTENT PAIN. AT THE TIME OF CONVERSION SURGERY, THE SURGEON FOUND THE FEMORAL COMPONENT TO BE LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TGS UKA FEMORAL COMPONENT | UNICOMPARTMENTAL KNEE COMPONENT | HSX | ALEXANDRIA RESEARCH TECHNOLOGIES, LLC | F 0911002 8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |