OtherHTG
OPTETRAK
Received Aug 23, 2012 · Event occurred Jul 24, 2012
Report 1038671-2012-00120 · MDR key 2718776
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Product code (HTG)
Manufacturer (Exactech, Inc.)
Model (200-02-32)
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
REVISED PATELLA WAS NOT RETURNED TO MFR FOR EVAL. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.