BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX FEMORAL IMPLANT WITH INSERTER

    MDR report key: 1286758 · Received January 5, 2009

    Report

    Report Number
    3006108336-2009-00001
    Event Type
    Other
    Date Received
    January 5, 2009
    Date of Event
    December 16, 2008
    Report Date
    January 5, 2009
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HWC
    PMA / PMN Number
    K073054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THIS FAILURE WAS TWO-FOLD. FIRST, THE TITANIUM WEDGE SCREW FRACTURED DURING IMPLANTATION. SECOND, THE SURGEON DID NOT DETECT THE SCREW FRACTURE AUDIBLY NOR DURING HIS ASSESSMENT OF IMPLANT FIXATION AFTER DEPLOYMENT. IT IS STANDARD PRACTICE FOR SURGEONS TO STRESS THE IMPLANT AFTER DEPLOYMENT TO VERIFY SUFFICIENT FIXATION STRENGTH. IF THE WEDGE SCREW IS FRACTURED, THE IMPLANT WILL NOT FIX THE TENDONS IN THE FEMORAL TUNNEL, AND THUS DURING THE STANDARD STRESS TEST OF THE IMPLANT, THE IMPLANT/GRAFT CONSTRUCT, WILL PULL OUT OF THE TUNNEL. IT IS THE OPINION OF CAYENNE MEDICAL THAT THE SURGEON DID NOT PERFORM AN ADEQUATE STRESS TEST OF THE IMPLANT. HOWEVER, WE ANALYZED POSSIBLE CHANGES THAT MAY MITIGATE THE RISK OF THIS OCCURRENCE. WORK HARDENED STAINLESS STEEL HAS A HIGHER TENSILE STRENGTH AND IS TOUGHER THAN GRADE 5 TITANIUM. FURTHERMORE, STAINLESS STEEL SCREWS CAN WITHSTAND HIGHER DEPLOYMENT TORQUE COMPARED TO TITANIUM SCREWS WHEN USED UNDER THE SAME CONDITIONS. CAYENNE MEDICAL IMPLEMENTED A CHANGE IN THESE IMPLANTS BY REPLACING THE TITANIUM SCREWS WITH STAINLESS STEEL SCREWS FOR ALL THE NEW MANUFACTURED UNITS. THE CHANGE WAS IMPLEMENTED IN (B)(6)2008. CAYENNE MEDICAL DID NOT TAKE ANY ACTION FOR EXISTING INVENTORY OF THE TITANIUM SCREW IMPLANTS, SINCE ACCORDING TO INTERNAL RISK MANAGEMENT PROCEDURES, THE RISK LEVEL WAS DETERMINED TO BE NEGLIGIBLE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, CAYENNE MEDICAL WAS NOTIFIED ABOUT THE POTENTIAL OF A TITANIUM SCREW FRACTURE IN A 29X9 MM FEMORAL IMPLANT THAT HAD BEEN IMPLANTED IN A PT IN (B)(6). THE SURGEON TOOK AN X-RAY IMAGE OF THE REPAIRED ACL 6 WEEKS POST-OP, AND NOTICED THAT THE FEMORAL IMPLANT LOOKED LIKE IT HAD BEEN MIGRATED OUT OF THE FEMORAL TUNNEL APPROXIMATELY 15MM. THE X-RAY WAS SENT TO CAYENNE MEDICAL FOR EVALUATION. AFTER REVIEWING THE X-RAY, CAYENNE MEDICAL CONCLUDED THAT THE IMPLANT HAD INDEED MIGRATED APPROXIMATELY 15MM OUT OF THE JOINT. THERE WAS NO EVIDENCE THAT ANY ANATOMICAL STRUCTURES OF THE KNEE WERE NEGATIVELY AFFECTED BY THE IMPLANT MIGRATION. CAYENNE MEDICAL RECOMMENDED THAT THE SURGEON ARTHROSCOPICALLY REVISE THE IMPLANT. A REVISION WAS PERFORMED ON THE PT ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APERFIX FEMORAL IMPLANT WITH INSERTER BONE SCREW HWC CAYENNE MEDICAL, INC. CM2909 088812008A

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention