BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 38MM CONST HUM LINER +2.5

    MDR report key: 21293089 · Received February 3, 2025

    Report

    Report Number
    1038671-2025-00616
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086686
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    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. D10: 300-01-13 - EQ HUMERAL STEM PRIMARY, PRESS FIT 13MM: B023467 320-02-38 - RS EXP GLENOSPHERE 38MM, +4MM OFFSET: 7152842 320-10-00 - EQ REV TRAY ADAPTER PLATE TRAY +0: B060508 320-15-03 - RS GLENOID PLATE POST AUG, 8 DEG, LEFT: A602205 320-15-05 - EQ REV LOCKING SCREW: A982144 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: B178458 320-20-26 - EQ REV CMPRSS SCRW LCK CAP KIT, 4.5 X 26MM: B178974 320-20-26 - EQ REV CMPRSS SCRW LCK CAP KIT, 4.5 X 26MM: B211737 320-20-26 - EQ REV CMPRSS SCRW LCK CAP KIT, 4.5 X 26MM: S549186 320-20-30 - EQ REV CMPRSS SCRW LCK CAP KIT, 4.5 X 30MM: B256774

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 WEEK AND 5 DAYS POST THE PREVIOUS LEFT SHOULDER REVISION SURGERY, THE SURGEON PERFORMED A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE DUE TO PERSISTENT INFECTION, AND DID A LIKE-FOR-LIKE EXCHANGE OF THE HUMERAL LINER. THE HUMERAL LINER WAS UNDAMAGED. 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
    1039596 145-DEG PE 38MM CONST HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086686

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization SEE H11.