FOUNDATION KNEE
Received Jun 21, 2012 · Event occurred Jun 5, 2012
Report 1644408-2012-00314 · MDR key 2640564
Device
Product problems
- Noise, Audible
Patient
65 YR
- Pain
Narrative
Description of Event or Problem
REVISION SURGERY - THE PT HAD SOME PAIN AND HEARD A "CLICKING".
Additional Manufacturer Narrative
THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY PAIN AND CLICKING AFTER 10.1 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. (B)(4). THE ROOT CAUSE FOR THE PAIN AND CLICKING WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.