3D KNE
Received Jul 19, 2012 · Event occurred Jun 28, 2012
Report 1644408-2012-00376 · MDR key 2671038
Device
Generic name
E-plus Insert, 11mm
Manufacturer
Encore Medical, L.p.Catalog number
392-11-707
Lot number
59601836
Product problems
- Device Operates Differently Than Expected
Patient
65 YR
- Erythema
- Swelling
Narrative
Description of Event or Problem
REVISION SURGERY - THE PATIENT HAD SWELLING AND REDNESS.
Additional Manufacturer Narrative
THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY SWELLING AND REDNESS AFTER TEN DAYS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. 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 SWELLING AND REDNESS WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.