OtherHSH
OPTETRAK
Received Oct 4, 2013 · Event occurred Sep 3, 2013
Report 1038671-2013-00145 · MDR key 3409239
Device
Product problems
- Device Slipped
Patient
Not reported
- Pain
Narrative
Additional Manufacturer Narrative
RETURNED DEVICES ARE CURRENTLY UNDERGOING ENGINEERING EVALUATION.
Description of Event or Problem
REVISION DUE TO TIBIAL LOOSENING. PT COMPLAINT OF PROGRESSIVELY INCREASING PAIN DURING AMBULATION. DURING REVISION, THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE AND EASILY REMOVED. SURGEON NOTED NOVERHANG ON THE MEDIAL SIDE. ALTHOUGH THERE WAS PRIMARILY A GOOD CEMENT MANTLE, THERE WAS LIMITED CEMENT CLOSE TO THE FINNED STEM. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6).