BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 36MM HUM LINER +2.5

    MDR report key: 20952537 · Received December 17, 2024

    Report

    Report Number
    1038671-2024-04894
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 21, 2024
    Report Date
    March 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K093275
    Adverse Event
    Yes
    Product Problem
    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 FOLLOWING SECTIONS WERE UPDATED: H6. THE FOLLOWING SECTIONS WERE CORRECTED: B2, D1, H6. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION AND/OR SUBLUXATION ARE KNOWN RISKS, AS OUTLINED IN THE IFU. 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. CONCOMITANTS: 6359752 308-01-06 - 6X80MM DISTAL STEM MODULAR CEMENTED; 6407869 308-09-00 - SMALL PROX BODY +0; 7020433 308-15-25 - TAPER LOCKING SCREW 25; A138866 308-10-25 - 25MM MIDDLE SEGMENT MODULAR; A593999 308-05-17 - DISTAL FIXATION RING HA 17.5; A894904 320-15-05 - EQ REV LOCKING SCREW; A898000 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; B003075 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; B008278 320-31-36 - GLENOSPHERE, 36MM; B024937 320-35-01 - SMALL GLENOID PLATE; S480781 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; S515189 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; S529980 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 MONTHS POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA), REVISION WAS PERFORMED AS THE SHOULDER HAD DISLOCATED AND "RAISED UP". THE SURGEON WAS UNABLE TO REDUCE WITH THE 36MM (+2.5MM) IN SITU SO THEY EXTRACTED THE LINER AND REPLACED IT WITH 36MM +0 AND WAS THEN ABLE TO REDUCE THE SHOULDER AND CLOSE UP. THE EVENT WAS UNRELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A 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
    292592 145-DEG PE 36MM HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization| R