BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACETABULAR SCREWS

    MDR report key: 2538503 · Received April 6, 2012

    Report

    Report Number
    1038671-2012-00043
    Event Type
    Other
    Date Received
    April 6, 2012
    Date of Event
    February 16, 2012
    Report Date
    April 6, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED SCREWS NOTED INWARD RADIAL DEFORMATION OF ONE SCREW HEAD RIM. THIS SCREW ALSO HAD A FRACTURE OF THE RIM AND FRETTING MARKS CONSISTENT WITH SCREW HOLE CONTACT. THE THREAD PEAKS WERE CRUSHED DOWN, CONSISTENT WITH RADIAL SCREW HOLE IMPINGEMENT DURING SCREW TIGHTENING. EVALUATION OF THE OTHER SCREW NOTED ABSENCE OF DEFORMATION AND FRACTURE PRESENT ON THE FIRST AND BURNISH MARKS CONSISTENT WITH EVEN SCREW HOLE CONTACT DURING TIGHTENING. THE DEVICE HISTORY RECORD REVIEWS PROVIDE ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS. REVIEW OF THE PRE-OPERATIVE PT RADIOGRAPHS NOTED AN OSTEOLYTIC LESION AS WELL AS NOTING THAT THE SCREW HEAD APPEARS TO BE PROTRUDING OUT OF THE SCREW HOLE CONSISTENT WITH THE SCREW NOT BEING FULLY SEATED IN THE ACETABULAR CUP. THE OSTEOLYTIC LESION IS CONSISTENT WITH THE BIOLOGICAL RESPONSE OF BONE TO A REACTIVE CONCENTRATION OF WEAR PARTICLES.

    Description of Event or Problem · 1

    REVISION OF HIP COMPONENTS APPROXIMATELY 5 YEARS POST OPERATIVELY DUE TO OSTEOLYTIC TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACETABULAR SCREWS HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention