OPTETRAK
Received Aug 23, 2012 · Event occurred Jul 24, 2012
Report 1038671-2012-00117 · MDR key 2718769
Device
Product problems
- Naturally Worn
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
REVISION OF KNEE COMPONENTS DUE TO SIGNIFICANT WEAR OF THE POSTERO-MEDIAL ASPECT OF THE INSERT. SURGEON REPORTED THAT PT WAS DOING FINE FROM A CLINICAL POINT OF VIEW AND WAS STABLE ON VARUS AND VALGUS STRESS TEST.
Additional Manufacturer Narrative
ENGINEERING EVAL OF THE RETURNED DEVICE NOTED ADHERENT PMMA BONE CEMENT ON BOTH THE MEDIAL AND LATERAL CEMENT POCKETS AS WELL AS IN THE TIBIAL UNDERCUTS. THE POSTERIOR EDGE OF THE MEDIAL ASPECT SHOWED METAL LOSS PRODUCING A SEMI-CIRCULAR GOUGE EXACTLY CONGRUENT TO THE SHAPE OF THE MEDIAL FEMORAL CONDYLE. THIS IS CONSISTENT WITH ARTICULATION BETWEEN THE TIBIAL TRAY AND FEMORAL CONDYLE. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.