PATELLO-FEMORAL TROCHLEAR COMPONENT
Received Apr 12, 2016 · Event occurred Apr 23, 2014
Report 1822565-2016-01170 · MDR key 5571463
Device
Product problems
- Nonstandard Device
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
- No Known Impact Or Consequence To Patient
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). ONE PF J SIZE 4 PRECOAT IMPLANT WAS RETURNED WITH THE COMPLAINT FOR REVIEW. PHOTO AND VISUAL EXAM REVEALED THE PRESENCE OF LOW DENSITY POLYETHYLENE (LDPE) RESIDUE ON THE IMPLANT. THE DEVICE IS 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 Z-0845-2016 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
IT IS REPORTED DURING SURGERY, UPON OPENING AN IMPLANT FOR USE, THE IMPLANT WAS FOUND WITH POLYETHYLENE PACKAGING WRAPPER ADHERED TO THE POLISHED SURFACE OF THE COMPONET.
Remedial action
- Recall