BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MIS HYBRID OFFSET SHELL INSERTER

    MDR report key: 2042207 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00621
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUS SEM EXAMINATION FOR SIMILAR REPORT SHOWED A MIXED CLEAVAGE-DIMPLE FRACTURE MODE AND APPEARED TO HAVE OCCURRED BY REPEATED IMPACT LOADING. EXAMINATION OF RETURNED DEVICE SHOWS THE HEX BOLT IS FRACTURED JUST BELOW THE HEAD. THE HEX BOLT HEAD SHOWS DAMAGE, AND THE FIRST TWO THREADS NEAREST THE HEAD SHOW THE CRESTS ARE FLATTENED. THE DEVICE EXHIBITS A NUMBER OF SCRATCHES AND IMPACTION MARKS ON THE SIDE OF THE BODY AT THE DISTAL END ABOVE WHERE THE BOLT IS LOCATED. THE TOP SURFACE OF THE KNOB ON THE BODY CONTAINS A NUMBER OF IMPACTION MARKS. A CRACK HAS PROPAGATED ON THE WELD LOCATED ON THE UNDERSIDE OF THE KNOB AND SHOWS SIGNS OF RUST. POTENTIAL FIELD AGE OF THE DEVICE IS APPROX 5.5 YEARS. THE SPECIFIC SEQUENCE OF EVENTS, WHICH TYPE OF SHELL WAS BEING IMPACTED, AND IF THE APPROPRIATE ADAPTER CAP WAS USED ARE ALL UNK. THE SURGICAL TECHNIQUE STATES "NOTE: DO NOT LEVER ON THE SHELL OR THE CUP INSERTER TO REPOSITION THE IMPLANT, AS DAMAGE MAY OCCUR TO THE THREADS OR INNER DIAMETER OF THE SHELL". IT IS POSSIBLE THE INSTRUMENT WAS IMPACTED ON ITS SIDE NEAR THE DISTAL END WHERE THE BOLT IS LOCATED, WHICH MAY HAVE CONTRIBUTED TO THE BOLT FRACTURE. GIVEN THE INFO PROVIDED AND ANALYSIS PERFORMED, A DEFINITIVE CAUSE CANNOT BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS ON THE SHELL INSERTER ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MIS HYBRID OFFSET SHELL INSERTER LXH ZIMMER, INC. 60342640

    Patients

    Seq Age Sex Outcome Treatment
    1