PATELLO-FEMORAL TROCHLEA COMPONENT
Received Apr 11, 2016 · Event occurred Nov 5, 2014
Report 1822565-2016-01138 · MDR key 5568929
Device
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
43 YR
- No Known Impact Or Consequence To Patient
- Not Applicable
- No Information
- No Known Impact Or Consequence To Patient
- Not Applicable
- No Information
Narrative
Additional Manufacturer Narrative
AS THE PRODUCT WAS ALREADY CEMENTED INTO THE PATIENT AT THE TIME OF THE EVENT, NO PRODUCT WAS RETURNED FOR REVIEW. THE DEVICE WAS USED FOR TREATMENT. THIS ISSUE HAS BEEN PREVIOUSLY INVESTIGATED AND AS PART OF CORRECTIVE ACTION, A NEW SUPPLIER FOR THE POLYETHYLENE BAGS HAS BEEN SELECTED AND TESTING COMPLETED TO ENSURE THERMAL RELIABILITY AND STABILITY OF THE NEW BAGS. FIELD ACTION (B)(4) WAS INITIATED ON JANUARY 11, 2016 TO REMOVE REMAINING AFFECTED UNITS FROM THE FIELD. THIS FIELD ACTION CONTAINS THE RELATED PART AND LOT NUMBER. THIS MDR WAS IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED RETROSPECTIVELY.
Description of Event or Problem
AFTER THE IMPLANT WAS CEMENTED IN THE PATIENT, THE RESIDENT ASSISTING THE SURGEON NOTICED A SMALL THIN CLEAR LAYER (ALMOST LIKE SHRINK WRAPPING) ON THE SURFACE OF THE IMPLANT. THE SUBSTANCE WAS COMPLETELY REMOVED, AND THE WOUND WAS CLOSED.
Remedial action
- Recall