BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD LAG SCREW OMEGA 80MM LENGTH

    MDR report key: 1924859 · Received December 8, 2010

    Report

    Report Number
    8031020-2010-00176
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K070454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE LAG SCREW HAD STARTED TO CUT MEDIALLY THROUGH THE FEMORAL HEAD INTO THE ACETABULUM. SURGEON REMOVED HARDWARE AND PUT A CEMENT STEM. HE USED A RELIANCE CM STEM AND HE PUT IN A TRIDENT HEMISPHERICAL CLUSTER ACETABULAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD LAG SCREW OMEGA 80MM LENGTH IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA M10216

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention