BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID OFFSET SHELL INSERTER

    MDR report key: 5662689 · Received May 18, 2016

    Report

    Report Number
    0001822565-2016-01624
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    April 15, 2016
    Report Date
    April 19, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE HYBRID OFFSET SHELL INSERTER WITH SHELL IMPACTION ADAPTOR AND TM CLUSTER HOLE SHELL WERE RETURNED FOR REVIEW. THE PIECES WERE ASSEMBLED WHEN RECEIVED, AND DISASSEMBLED FOR INSPECTION. VISUAL INSPECTION REVEALS THAT THE INSERTER SHOWS SIGNS OF WEAR AND TEAR, SUGGESTING EXTENSIVE USE. THE FREQUENCY OF USE OF THIS INSTRUMENT IS UNKNOWN. THE INSERTER HEX BOLT IS FRACTURED AT THE HEAD AND SHAFT JUNCTION. THE BOLT WAS RETAINED AND CONSTRAINED BY THE INSERTER TIP, KEEPING THE SHELL FROM BEING DISENGAGED. THE THREADING STILL ACCEPTS A 25-2003-304-00 THREAD RING GAUGE. SHELL THREADS WERE DAMAGED DURING DISASSEMBLY. THE SHELL THREADS WILL NOT ACCEPT A 25-2003-359-00 THREAD PLUG GAUGE. THE SHELL INSERTER¿S POTENTIAL FIELD AGE IS APPROXIMATELY 4 YEARS AND 4 MONTHS BASED ON MANUFACTURING DATE. DIMENSIONAL ANALYSIS WAS FOUND TO BE CONFORMING. DEVICE HISTORY REPORTS WERE REVIEWED AND SHOWED NO DEVIATIONS OR ANOMALIES IN THE MANUFACTURING PROCESS OF ANY OF THESE DEVICES. THESE DEVICES ARE USED FOR TREATMENT. NO PREVIOUS COMPLAINTS WERE FOUND FOR THE SHELL PART AND LOT COMBINATION REPORTED. PREVIOUS INVESTIGATION CAPTURES THE FAILURE MODE OF BOLT FRACTURE SPECIFIC TO HYBRID OFFSET SHELL INSERTER. THE FAILURE OCCURS DUE TO A REDUCED CROSS-SECTIONAL THICKNESS AT THE ROOT OF THE BOLT. THIS IS CAUSED BY THE DRILL POINT THAT IS USED IN THE HEX MANUFACTURING. A MATERIAL CHANGE (MC) WAS IMPLEMENTED TO INCREASE THE HEX BOLT HEAD HEIGHT, ELIMINATE THE DRILL POINT, AND INCREASE THE SHANK FILLET RADIUS, THUS REDUCING STRESS IN THE FAILURE REGION. BECAUSE THIS DEVICE PRECEDES THAT DESIGN CHANGE, THE LIKELY CAUSE FOR THE REPORTED ISSUE IS A PREVIOUSLY ADDRESSED DESIGN ISSUE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ACETABULAR CUP INSERTER WOULD NOT DISCONNECT FROM THE IMPLANT AND THE IMPLANT HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318843 HYBRID OFFSET SHELL INSERTER LXH LXH ZIMMER, INC. N/A 61948584

    Patients

    Seq Age Sex Outcome Treatment
    1