BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 42MM HUM LINER +0

    MDR report key: 20723253 · Received November 19, 2024

    Report

    Report Number
    1038671-2024-04421
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    September 27, 2024
    Report Date
    February 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    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 REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, PROSTHESIS WEAR COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. 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

    PENDING INVESTIGATION. CONCOMITANTS: A10012 - GPS IMPLANT KIT V2 05001221165 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE 6917433 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6943184 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG 6973533 531-20-00 - SHLDR GPS RVRS DRILL KIT 6974440 531-78-20 - SHOULDR GPS HEX PINS KIT 6984262 531-78-20 - SHOULDR GPS HEX PINS KIT 6984279 320-15-05 - EQ REV LOCKING SCREW 6985677 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6999544 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM 7026350 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S213580 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM S255952 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S273456 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S273503

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS AND 1 MONTH POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT UNDERWENT REVISION AT WHICH TIME THE LINER WAS REVISED AS PART OF THE RECALL. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO 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
    93580 145-DEG PE 42MM HUM LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE H11.