OtherHTG
OPTETRAK
Received Jun 27, 2012 · Event occurred Apr 6, 2012
Report 1038671-2012-00082 · MDR key 2648612
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Pain
- Swelling
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
REVISION APPROXIMATELY FOUR YEARS POST OPERATIVELY. AT ONE YEAR POST OPERATIVE FOLLOW UP, PT COMPLAINED OF PAIN, DIFFUSE SWELLING (ANTEROLATERALLY) AND DIFFICULTY AMBULATING. CONSERVATIVE TREATMENTS WERE GIVEN THROUGH THE TWO YEAR FOLLOW UP AND BEYOND. LAST RECORDED VISIT WAS APPROXIMATELY 29TH MONTH POST OPERATIVELY.
Additional Manufacturer Narrative
EXPLANTED DEVICE WAS NOT RETURNED TO PRODUCT MANUFACTURER FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.