3D KNEE
Received Dec 12, 2012 · Event occurred Nov 27, 2012
Report 1644408-2012-00650 · MDR key 2875442
Device
Generic name
Dcm Insert, 9mm
Manufacturer
Encore Medical, L.p.Catalog number
391-09-612
Lot number
53929018
Product problems
- Loose or Intermittent Connection
Patient
82 YR
- No Code Available
Narrative
Description of Event or Problem
REVISION SURGERY - THE SCREW IN THE POLYETHYLENE OF THE PT'S KNEE PROSTHESIS HAD LOOSENED AND NEEDED TO BE SWAPPED FOR A NEW INSERT.
Additional Manufacturer Narrative
THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A LOOSE SCREW FOR A POLY INSERT AFTER 4.3 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 FOURTH COMPLAINT FOR THIS PART NUMBER: TWO DUE TO INFECTION AND ONE DUE TO TRAUMA. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE LOOSE SCREW AND POLY INSERT WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.