BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOME IMPACTION ADAPTER

    MDR report key: 2102905 · Received May 4, 2011

    Report

    Report Number
    1822565-2011-01115
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED ADAPTER IS FRACTURED WITHIN THE CONNECTION FEATURE. THE CRACK ORIGINATED NEAR THE LOCATION WHERE IMPINGEMENT OCCURS WITH THE LOCKING PIN OF THE OFFSET IMPACTOR. THE LOCKING PIN IMPINGES BOTH SIDE OF THE FLANGE ON THE CONNECTION FEATURE AND ONE SIDE WAS FRACTURED AWAY. THE FRACTURE SURFACE TENDS TO INDICATE INITIATION AT THE CORNER OF THE UNDERCUT AND THE LOCATION SLOT. THE IMPACTION SURFACE OF THE DOME IMPACTOR ADAPTER WAS UNDAMAGED. THE SPECIFIC CIRCUMSTANCES CONCERNING THE IMPACTS LEADING UP TO THE FRACTURE ARE UNK. FRACTURE CAN OCCUR FOR A VARIETY OF REASONS, SOME OF WHICH ARE: SECONDARY DAMAGE FROM HANDLING LEADING TO A STRESS CONCENTRATION IN THIS REGION; REPETITIVE AUTOCLAVE CYCLES LEADING TO A REDUCTION IN MATERIAL STRENGTH; AGGRESSIVE CLEANING AGENTS NOT APPROVED FOR THIS DEVICE (B+) LEADING TO A MATERIAL STRENGTH DEGRADATION; THERMAL CYCLING / AUTOCLAVE CYCLING LEADING TO PRE-CRACKS IN THE RIM RADIUS REGION; SHARP EDGE PRESENT WITHIN THE CONNECTION GEOMETRY LEADING TO INCREASED STRESS IN THE ROOT; EXCESSIVE IMPACT FORCES USED ON THE DEVICE. BASED ON THE INFO AVAILABLE A DEFINITIVE CAUSE FOR FRACTURE CANNOT BE DETERMINED AT THIS TIME. THE DEVICE MEETS PRINT SPECIFICATION WHERE MEASURED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD CAME OFF DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOME IMPACTION ADAPTER HWA ZIMMER INC 61549739

    Patients

    Seq Age Sex Outcome Treatment
    1