FOUNDATION KNEE
Received Sep 5, 2012 · Event occurred Aug 29, 2012
Report 1644408-2012-00484 · MDR key 2739217
Device
Product problems
- Naturally Worn
Patient
83 YR
- No Code Available
Narrative
Description of Event or Problem
REVISION SURGERY - THE TIBIAL INSERT WAS WORN, THE SURGEON HAD TO REPLACE IT.
Additional Manufacturer Narrative
THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY SYMPTOMS RELATED TO A WORN POLY INSERT AFTER 12.6 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE SECOND COMPLAINT FOR THIS PART NUMBER, THE FIRST WAS FOR WEAR. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE WORN POLY WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.