BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP STRAIGHT SHELL INSERTER

    MDR report key: 1923216 · Received November 9, 2010

    Report

    Report Number
    1822565-2010-01096
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS UNK IF PROPER SURGICAL TECHNIQUE WAS FOLLOWED FOR INSERTING THE CUP. BASED ON THE AVAILABLE INFO AND OBSERVATIONS, THE DISTAL THREAD BREAKAGE MAY HAVE BEEN DUE TO ONE OR A COMBINATION OF THE FOLLOWING OCCURRENCES: THE DEVICE WAS USED WITHOUT AN ADAPTER, WHICH COULD HAVE LED TO HIGH STRESS ON THE THREADS CAUSING THEM TO BREAK; INSUFFICIENT THREAD ENGAGEMENT DURING IMPACTION MAY HAVE LEAD TO HIGH STRESS ON THE DISTAL TREADS CAUSING THEM TO BREAK; OFF-AXIS IMPACTION OF THE COMPONENT EITHER WITH SUFFICIENT OR INSUFFICIENT THREAD ENGAGEMENT; THE DEVICE WAS INADVERTENTLY DROPPED OR DAMAGED DURING THE CLEANING PROCESS; CUP IMPACTED WHILE NOT FULLY TIGHTENED ON THE ADAPTER, RESULTING IN ALL IMPACT LOADING AND BENDING MOMENTS ABSORBED THROUGH THREADS. HOWEVER, A DEFINITIVE CAUSE CANNOT BE DETERMINED WITH CERTAINTY AT THIS TIME. EVAL: THE DEVICE HISTORY RECORDS INDICATE THE INSERTER WAS WITHIN MFG, INSPECTION AND PACKAGING SPECIFICATIONS WHEN PRODUCED. THE INSERT HAS A POTENTIAL SERVICE LIFE OF 8 MONTHS WHEN RETURNED. THE INSERTER SHOWED SIGNS OF USAGE FROM MULTIPLE DEFORMATIONS ON THE IMPACTION HEAD. THE LOWER SHAFT NEAR THE CUP END HAD SOME SCRATCHING AS WELL AS SEVERAL DEFORMATIONS IN THE CIRCUMFERENTIAL DIRECTION JUST ABOVE THE UPPER CIRCULAR ACCESS HOLE OPPOSITE THE ALIGNMENT POST. THE THREADED TIP IS FRACTURED FROM THE ROOT OF THE SECOND THREAD IN A BRITTLE MANNER AND THE CRACK SURFACE PROPAGATES AT AN ANGLE TO THE CENTER OF THE SCREW WHERE A NEARLY VERTICAL SHEAR TEAR COMPLETES THE FRACTURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSERTER THREADS BROKE OFF IN THE CUP AND THE INSERTER BECAME LOOSE. THE CUP WAS REMOVED AND THREADS CLEANED OUT THEN IMPLANTED THE CUP WITH ANOTHER INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP STRAIGHT SHELL INSERTER HIP INSTRUMENT LXH ZIMMER, INC. 61419370

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR