FDA Adverse Event
Injury
Summary report: N
UNICOMPARTMENTAL KNEE COMPONENT
MDR report key: 2720640
·
Received August 28, 2012
Report
- Report Number
- 3004594167-2012-00008
- Event Type
- Injury
- Date Received
- August 28, 2012
- Date of Event
- July 30, 2012
- Report Date
- August 7, 2012
- Manufacturer
- ALEXANDRIA RESEARCH TECHNOLOGIES, INC.
- Product Code
- HSX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL POLY TIBIAL COMPONENT, LOT # 0904005, CAT # 100020, MFG. DATE: MAY 2009, EXP. DATE: NOVEMBER 2011. 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 PRESENTED WITH FEMORAL COMPONENT THAT APPEARED TO HAVE MIGRATED AND BELIEVED TO BE LOOSE. CONVERTED TO TOTAL KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICOMPARTMENTAL KNEE COMPONENT | HSX | ALEXANDRIA RESEARCH TECHNOLOGIES, INC. | 0910025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |