BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN GAMMA3 RC LAG SCREW

    MDR report key: 19388046 · Received May 23, 2024

    Report

    Report Number
    0009610622-2024-00200
    Event Type
    Death
    Date Received
    May 23, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 23, 2024
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "A FINAL REPORT WAS RECEIVED OF RETROSPECTIVELY COLLECTED DATA, WHICH COMPARES THE CLINICAL AND RADIOLOGIC OUTCOMES OF U-BLADE GAMMA3 NAIL AND STANDARD GAMMA3 NAIL FOR ALL TYPES OF EXTRACAPSULAR FRACTURES OF THE HIP WITH ROTATIONAL INSTABILITY. THE STUDY INCLUDED ALL PATIENTS HOSPITALIZED FOR OSTEOPOROTIC EXTRACAPSULAR FRACTURE OF THE HIP WITH ROTATIONAL INSTABILITY WHO ENTERED THE UNITS OF ORTHOPEDIC SURGERY AND TRAUMATOLOGY OF THE SELECTED HOSPITALS FOR THE STUDY, DATA COLLECTION BEGAN MARCH 2017. THE PRECISE DATES OF THE COMPLICATIONS AT VARIOUS TIMEPOINTS WERE NOT REPORTED AND NO FURTHER DETAILED INFORMATION REGARDING COMPLICATIONS WAS AVAILABLE. SEVERE MECHANICAL COMPLICATIONS OF HIP FRACTURES GENERATE SIGNIFICANT FUNCTIONAL LIMITATION IN ELDERLY PATIENTS AND USUALLY REQUIRE SURGICAL REOPERATION. IT IS REPORTED THAT ONE PATIENT HAD DIED WHILE WAITING FOR A REVISION SURGERY DUE TO AN INTRAOPERATIVE MISTAKE (CUT THROUGH). THE DATE OF THE INITIAL IMPLANT SURGERY OR PATIENT'S DEATH IS NOT AVAILABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12333 UNKNOWN GAMMA3 RC LAG SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death