BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE 145-DEG PE 46MM HUM LINER +0

    MDR report key: 20280052 · Received September 23, 2024

    Report

    Report Number
    1038671-2024-03658
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    September 1, 2024
    Report Date
    September 23, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086730
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 300-30-06 - EQUINOXE PRESERVE STEM 6MM: 6726262; 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE: 4405310; 320-15-01 - EQ REV GLENOID PLATE: 6589233; 320-15-05 - EQ REV LOCKING SCREW: 6744086; 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6369627; 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: S128309; 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: S128349; 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM: 6210169; 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 6715096.

    Description of Event or Problem · 0

    APPROXIMATELY 3 YEAR(S), 8 MONTH(S) AND 13 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. SUBJECT WAS GOLFING, HEARD POPPING AND PAIN. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION WITH THE REMOVAL OF THE PRESERVE STEM (RTSA), HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, AND GLENOID BASE PLATE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591149 EQUINOXE 145-DEG PE 46MM HUM LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086730

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male SEE H11.