BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 24483048 · Received March 2, 2026

    Report

    Report Number
    1220246-2026-01122
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    July 1, 2021
    Report Date
    March 2, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 03-FEB-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2021 BY THE JOURNAL OF SURGICAL ONCOLOGY TITLED ¿IS OSSEOUS REATTACHMENT OF THE GREATER TROCHANTER NECESSARY COMPARED TO SOFT-TISSUE-ONLY ABDUCTOR REPAIR IN PROXIMAL FEMORAL MEGAPROSTHESIS RECONSTRUCTION?¿. THE STUDY REVIEWED FIFTY-THREE (53) PATIENTS WHO UNDERWENT ABDUCTOR REPAIR IN PROXIMAL FEMUR MEGAPROSTHESIS: BONY VS SOFT-TISSUE ARTHREX FIBERWIRE TO ADDRESS SOFT TISSUE APPROXIMATION AND/OR LIGATION. DURING THE TWENTY-THREE (23) MONTH FOLLOW-UP PERIOD, TWENTY-FOUR (24) PATIENTS EXPERIENCED BONY REATTACHMENT FAILURE. REF: GROUNDLAND, J., BROWN, J., JONES, K. & RANDALL, R. L. IS OSSEOUS REATTACHMENT OF THE GREATER TROCHANTER NECESSARY COMPARED TO SOFT-TISSUE-ONLY ABDUCTOR REPAIR IN PROXIMAL FEMORAL MEGAPROSTHESIS RECONSTRUCTION? J SURG ONCOL 124, 115-123, DOI:10.1002/JSO.26477 (2021).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539690 UNK POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown