BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 25260918 · Received May 22, 2026

    Report

    Report Number
    3003898228-2026-00002
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    FH INDUSTRIE
    Product Code
    KWS
    PMA / PMN Number
    K112193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTRAPROTHETIC DISLOCATION. WEAR OF THE POLYETHYLEN. THE GLENOSPHERE AND THE HUMERAL INSERT WERE REPLACED DURING A REVISION SURGERY - THE REVISION WAS PERFORMED THE (B)(6) 2026. PATIENT REVISED SURGICALY WITH IMPLANTS REMOVALS AND CHANGED FOR THE GLENOPHERE AND THE HUMERAL INSERT. THE INCIDENT OCCURRED WITH CE REFERENCES (B)(4) (GLENOSPHERE - BATCH J05577) AND (B)(4),(HUMERAL INSERT - BATCH K01900). THERE IS NO FDA EQUIVALENT FOR REFERENCE (B)(4). FOR REFERENCE (B)(4), THE FDA EQUIVALENT IS 265141.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321201 ARROW ARROW STD HUMERAL INSERT D36 H00 KWS FH INDUSTRIE

    Patients

    Seq Age Sex Outcome Treatment
    1