BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS MINIMALLY INVASIVE GROWER (MIG)

    MDR report key: 11981476 · Received June 11, 2021

    Report

    Report Number
    3004105610-2021-00088
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 19, 2021
    Report Date
    August 10, 2021
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING CLOSED AS A DUPLICATE OF FDA REF 3004105610-2021-00076.

    Description of Event or Problem · 0

    PATIENT SPECIFIC CASE INFORMATION FOR THE PATIENT'S RIGHT PROXIMAL HUMERAL MIG NOTES: "CURRENTLY HAS PROXIMAL HUMERUS MIG. DISTAL FIXATION FAILING (SCREW BACKING OUT). SUPER DISTAL SO NEED TO CONVERT TO HINGE ELBOW."

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS SIMILAR TO A DEVICE APPROVED FOR COMPASSIONATE USE IN THE UNITED STATES. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 1

    PATIENT SPECIFIC CASE INFORMATION FOR THE PATIENT'S RIGHT PROXIMAL HUMERAL MIG NOTES: "CURRENTLY HAS PROXIMAL HUMERUS MIG. DISTAL FIXATION FAILING (SCREW BACKING OUT). SUPER DISTAL SO NEED TO CONVERT TO HINGE ELBOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881100 PROXIMAL HUMERUS MINIMALLY INVASIVE GROWER (MIG) PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS STANMORE IMPLANTS WORLDWIDE PIN 22285

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R