OtherHTG
OPTETRAK
Received Dec 12, 2012 · Event occurred Sep 6, 2011
Report 1038671-2012-00149 · MDR key 2886267
Device
Product problems
- Insufficient Device Problem Information
Patient
66 YR
- Pain
Narrative
Description of Event or Problem
REVISION OF KNEE COMPONENTS DUE TO PAIN. THIS DEVICE IS ASSOCIATED WITH THE EVENT INITIALLY REPORTED IN 1038671-2012-0010, 1038671-2012-0011, 1038671-2012-0012.
Additional Manufacturer Narrative
PATELLA DEVICE WAS NOT RETURNED TO MFR FOR INVESTIGATION. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.