BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11404910 · Received March 3, 2021

    Report

    Report Number
    1038671-2021-00087
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    February 10, 2021
    Report Date
    May 13, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862083968
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF EITHER OFF-AXIS IMPACTION OR IMPINGEMENT WITH SOFT TISSUE OR BONE DURING IMPLANTATION LEADING TO INCOMPLETE ENGAGEMENT OF THE TAPER AND SUBSEQUENT DISASSOCIATION OF THE HUMERAL HEAD AND REPLICATOR PLATE. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT RADIOGRAPHS FROM THE INDEX PROCEDURE. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D4) SERIAL NUMBER: (B)(6), EXPIRATION DATE: 16-DEC-2025. (D11) CONCOMITANT DEVICE(S): 300-20-02, 5906793 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 300-10-45, 5082349 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. (H4) DEVICE MANUFACTURE DATE: 18-DEC-2015.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-10-45, 29237022 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. TORQUE SCREW.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 20 DAYS AFTER THE INITIAL RIGHT TSA ON THIS (B)(6) Y/O MALE PATIENT, THE HUMERAL HEAD DISASSOCIATED FROM REPLICATOR PLATE. A REVISION INCLUDED REPLACING THE REPLACED 4.5 REPLICATOR, TORQUE SCREW, AND 53 MM HUMERAL HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303439 EQUINOXE HUMERAL HEAD TALL, 53MM (BETA) KWT EXACTECH, INC. 310-02-53 UNK 10885862083968

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R SEE H10.