BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 42MM HUM LINER +2.5

    MDR report key: 24712338 · Received March 30, 2026

    Report

    Report Number
    1038671-2026-00344
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 27, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086709
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-30-09 - EQUINOXE PRESERVE STEM 9MM 7182971. 320-06-42 - GLENOSPHERE 42MM 7123819. 320-15-01 - EQ REV GLENOID PLATE 7223112. 320-15-05 - EQ REV LOCKING SCREW 7187181. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 7177952. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AND 1 MONTH POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO POLY DISASSOCIATION. THE POLY WAS RECALLED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779120 145-DEG PE 42MM HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086709

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R SEE H11.