FOUNDATION KNEE
Received Nov 9, 2012 · Event occurred Oct 29, 2012
Report 1644408-2012-00598 · MDR key 2845076
Device
Generic name
All-poly Sombrero Tri-peg Patella
Manufacturer
Encore Medical, L.p.Catalog number
120-01-032
Lot number
469A1002
Product problems
- Naturally Worn
Patient
78 YR
- No Code Available
Narrative
Description of Event or Problem
REVISION SURGERY- THE PATELLA WAS WORN AND NEEDED TO BE REPLACED.
Additional Manufacturer Narrative
THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY SYMPTOMS RELATED TO A WORN PATELLA AFTER 1.3 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 TENTH COMPLAINT FOR THIS PART NUMBER: TWO FOR WEAR, TWO DUE TO INFECTION, TWO REVISIONS, ONE PACKAGING ISSUE, ONE MACHINING ISSUE, AND ONE FOR STABILITY/POOR JOINT. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE WORN PATELLA WAS NOT DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.