FOUNDATION KNEE
Received Sep 5, 2012 · Event occurred Aug 20, 2012
Report 1644408-2012-00475 · MDR key 2739220
Device
Generic name
Constrained Revision Ps Insert 13mm Cm
Manufacturer
Encore Medical, L.p.Catalog number
370-13-506
Lot number
59601332
Product problems
- Device Operates Differently Than Expected
Patient
71 YR
- No Code Available
Narrative
Description of Event or Problem
REVISION SURGERY - THE PATIENT'S IMPLANTS WERE TOO TIGHT. THE SURGEON REVISED TO LENGHTEN MOTION BY POLYETHYLENE EXCHANGE.
Additional Manufacturer Narrative
THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A TIGHT JOINT WITH LIMITED RANGE OF MOTION AFTER 4.7 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED. 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 FIRST COMPLAINT FOR THIS PART NUMBER. THE ROOT CAUSE FOR THE TIGHT JOINT WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.