BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGP II ACETABULAR COMPONENTS BONE SCREW

    MDR report key: 2042210 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00550
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    March 16, 2010
    Report Date
    March 16, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE FRACTURE OCCURRED BELOW THE LEVEL OF THE AUGMENT, ALLOWING THE SURGEON TO FIX THE AUGMENT USING OTHER SCREWS THROUGH ALTERNATE SCREW HOLES. THE FRACTURED HEAD OF THE SCREW WAS RETURNED. SEM ANALYSIS SHOWS SIGNS THAT THE FRACTURE, "OCCURRED BY OVERLOAD IN BENDING AND TORSION." THE MOST LIKELY CAUSE OF THE FRACTURED SCREW IS COMBINED STRESSES FROM TORSION AND BENDING APPLIED TO THE SCREW DURING INSERTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREW SHEERED OFF INSIDE THE AUGMENT SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGP II ACETABULAR COMPONENTS BONE SCREW JDI ZIMMER, INC. 60796168

    Patients

    Seq Age Sex Outcome Treatment
    1