3D KNEE
Received Aug 16, 2011 · Event occurred Aug 3, 2011
Report 1644408-2011-00457 · MDR key 2222603
Device
Generic name
3dknee Tibial Insert - Dcm
Manufacturer
Encore Medical, L.p.Catalog number
10/31/2011
Lot number
53813306
Product problems
- Unstable
Patient
72 YR
- Arthralgia
Narrative
Additional Manufacturer Narrative
THE REASON FOR THE REVISION SURGERY WAS TO REMEDY PAIN 3 YEARS AFTER PRIOR SURGERY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THERE IS NO INFORMATION REPORTED ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THE ROOT CAUSE FOR PAIN WAS DETERMINED TO BE INSTABILITY. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. THIS IS THE 18TH COMPLAINT FOR THIS PART NUMBER. AS ORIGINALLY REPORTED, THE SURGEON THOUGHT AN X-RAY SHOWED POSITIONING PROBLEM WITH THE INSERT BUT DEEMED THIS TO BE CORRECT AND CONCLUDED THAT INSTABILITY CAUSED PAIN. THE ROOT CAUSE FOR INSTABILITY WAS NOT DETERMINED WITH CONFIDENCE.
Description of Event or Problem
REVISION SURGERY - DUE TO ANTERIOR KNEE PAIN, IT WAS THOUGHT A CT SCAN INDICATED AN INTERNALLY ROTATED TIBIAL TRAY, BUT FOUND THE TRAY TO BE POSITIONED PROPERLY. INTRA OP, THE SURGEON DECIDED THE KNEE WAS UNSTABLE AND REMOVED AND POLY INSERT. THE SURGEON IMPLANTED A MORE CONSTRAINED POLE INSERT, THE ORIGINAL INSERT DID NOT FAIL.