3D KNEE
Received Sep 5, 2012 · Event occurred Aug 27, 2012
Report 1644408-2012-00474 · MDR key 2739191
Device
Generic name
Dcm Insert 9mm
Manufacturer
Encore Medical, L.p.Catalog number
391-09-612
Lot number
59600493
Product problems
- Device Slipped
Patient
58 YR
- No Code Available
Narrative
Description of Event or Problem
REVISION SURGERY - THE PATIENT FELL AND LOOSENED THE PRIMARY INSERT.
Additional Manufacturer Narrative
THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A LOOSE INSERT AFTER NINE MONTHS OF PATIENT USE. 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 AND WAS KEPT BY THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT. ONCE PIECE WAS DISPOSITIONED AS SCRAP AND NOT USED IN THE LOT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE THIRD COMPLAINT FOR THIS PART NUMBER: TWO DUE TO INFECTION. THE ROOT CAUSE OF THE LOOSE INSERT WAS MOST LIKELY DUE TO THE PATIENT FALLING. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.