ZIMMER PATELLOFEMORAL TROCHLEAR COMPONENT

Additional Manufacturer Narrative

NO DEVICE OR PHOTOGRAPHS WERE WITH THE COMPLAINT FOR AN EVALUATION; THEREFORE, A VISUAL AN PHYSICAL EXAMINATION ON THE CONDITION OF THE DEVICE WAS NOT POSSIBLE. DEVICE HISTORY RECORDS REVIEW WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH DID NOT REVEAL ANY OTHER COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATION. THE LOW DENSITY POLYETHYLENE (LDPE) ADHESION ISSUE HAS BEEN INVESTIGATED AND ADDRESSED BY CORRECTIVE AND PREVENTATIVE ACTION. A RISK ASSESSMENT INDICATES THAT THE LIKELIHOOD OF A TOXIC EFFECT FROM THE LDPE BAGS IS NEGLIGIBLE. ZIMMER HAS DONE TESTING THAT SHOWS THE RESIDUE CAN BE REMOVED WITH A CLOTH MOISTENED WITH WATER OR ISOPROPYL ALCOHOL. THE LOT WAS MANUFACTURED PRIOR TO CORRECTIVE AND PREVENTIVE ACTIONS TAKEN. 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. IMPLANTED IN PATIENT.

Description of Event or Problem

IT WAS REPORTED THAT POLYETHYLENE WRAP ADHERED TO THE IMPLANT AND WAS NOTED MELTED ON SEVERAL SIDES OF THE IMPLANT. THE HOSPITAL TEAM HAD DIFFICULTY REMOVING THE PLASTIC FROM THE IMPLANT BUT WITH SOME WATER & INSTRUMENTS, THEY WERE ABLE TO REMOVE THE POLYTHENE WRAP AND IMPLANT THE COMPONENT.