InjuryHSH
OPTETRAK FEMORAL COMPONENT
Received Oct 7, 2014 · Event occurred May 9, 2012
Report 1038671-2014-00526 · MDR key 4176645
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
REVISION DUE TO INFECTION. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THE SURGEON DOES NOT BELIEVE THE EVENT WAS DEVICE RELATED.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.