BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM HUMERAL LINER +0

    MDR report key: 16069135 · Received December 29, 2022

    Report

    Report Number
    1038671-2022-01641
    Event Type
    Injury
    Date Received
    December 29, 2022
    Date of Event
    December 8, 2022
    Report Date
    March 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: CONCOMITANTS: 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM, 1907518, 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE, 1992020, 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5, 1817829, 320-15-01 - EQ REV GLENOID PLATE, 1973090, 320-15-05 - EQ REV LOCKING SCREW, 1996212, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, 1998732, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 2002255, 2002257, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM, 1848305, 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM, 1921521, 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM, 1990815, ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE INSTABILITY AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED INSTABILITY COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 69 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2011, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 11 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD OSTEOLYSIS OF THE PROXIMAL HUMERUS DUE TO POLY WEAR FROM THE HUMERAL LINER. PATIENT HAD INSTABILITY DUE TO SOFT TISSUE AND BONE LOSS FROM THE POLY WEAR. THEY REVISED THE PATIENT WITH A NEW HUMERAL LINER, HUMERAL ADAPTER TRAY AND NEW GLENOSPHERE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL WILL NOT RELEASE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354058 EQUINOXE REVERSE 38MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention