BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE FEMORAL IMPACTOR

    MDR report key: 11260917 · Received February 1, 2021

    Report

    Report Number
    1818910-2021-02185
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    November 13, 2020
    Report Date
    November 13, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWA
    UDI-DI
    10603295130222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY, EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. ROOT CAUSE AND CORRECTIVE ACTION ARE DOCUMENTED IN THE CAPA SYSTEM. THE INVESTIGATION DURING CAPA 003835 FOUND THAT THE ROOT CAUSE IS ATTRIBUTED TO INADEQUATE DESIGN. THE MANUFACTURING PROCESS INTRODUCES DEFECTS INTO THE PART DURING PRODUCTION THAT IS EXPLOITED BY HIGH LOADS DURING USE. THIS WEAKNESS LEADS TO LOW CYCLE FATIGUE CRACKING THAT WEAKENS THE PART AND LEADS TO CATASTROPHIC FAILURE. THE GEOMETRY CONTAINS A NATURAL STRESS RAISER AT THE CONNECTION FEATURE THAT CONCENTRATES STRESSES IN THIS REGION WHERE THE DEFECT IS PRESENT. THE COMBINATION OF THESE FACTORS HAVE CONTRIBUTED TO THE FAILURE OF THE THREE IMPACTORS (RP, FB & FEM). DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTOR COULD NOT BE STERILIZED DUE TO CRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155339 ATTUNE FEMORAL IMPACTOR ATTUNE INSTRUMENTS : IMPACTORS HWA DEPUY IRELAND - 9616671 2544-01-006 AU4300981 10603295130222

    Patients

    Seq Age Sex Outcome Treatment
    1