BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8758403 · Received July 3, 2019

    Report

    Report Number
    1038671-2019-00360
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    April 5, 2019
    Report Date
    February 6, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862268129
    PMA / PMN Number
    K143659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION INITIAL OR PROLONGED. (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K143659. (H3) THE DISLOCATION REPORTED WAS LIKELY THE RESULT OF THE ¿0° RETROVERSION IN COMBINATION WITH A TOO LARGE PROXIMAL HUMERUS¿ AND/OR THE PATIENT¿S ANATOMY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND X-RAYS WERE NOT PROVIDED. (H6) EVALUATION CODES: 2374, 2993. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR. (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 05-APR-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 320-10-05 HUM-ADPTPL 5 MM, 320-15-05 GLNSPHRN-SCHRAUBE, 320-20-26 KOMPR-SCHR,VERSCHL-KAP Ø 4,5 MM, L 26 MM, 320-20-26, 320-01-38 GLNSPHRE 38 MM, 320-38-00 HUM-INLAY Ø 38 MM, 0°, 320-15-01 GLNDPL,REV, 320-20-00 DREHM-SCH,REV, 308-01-09 DISTALER SCHAFT HRP 9 X 80 MM, 308-05-19 KRAGEN DIST. SCHAFT HRP 19,5 MM, 308-15-01 KONUS-VERRIEG.SCHR. HRP 0 MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT RECEIVED AN HRP PROSTHESIS DURING REVISION OF A COMPETITOR¿S DEVICE DUE TO OSTEONECROSIS OF THE PROXIMAL HUMERUS. DURING AN INITIAL REVISION ATTEMPT EARLIER THE SAME MONTH, AN INFECTION WAS FOUND, AND A SPACER IMPLANTED. THE TUBERCULII WERE FULLY NECROTIZED AND THE ROTATOR CUFF NOT RE-FIXABLE. DUE TO THIS, A LARGE PROXIMAL HUMERAL BODY IN 0°RETROVERSION AND A RTSA WAS IMPLANTED. AT THE TIME OF HIS LAST FOLLOW-UP, THE PATIENT WAS ABLE TO ELEVATE HIS ARM UP TO 120°, WITHOUT ANY SIGNIFICANT ROTATION POSSIBLE. ALTHOUGH SATISFIED WITH THE FUNCTION, THE JOINT TENDS TO DISLOCATE ANTERIORLY WHILE SLEEPING AND UNDER STRESS CAUSING ANTERIOR MOVEMENT OF THE PROXIMAL HUMORUS. THE SURGEON BELIEVES THIS IS DUE TO THE 0° RETROVERSION IN COMBINATION WITH A TOO LARGE PROXIMAL HUMERUS AND IS PLANNING TO IMPLANT A SMALLER SIZE OF THE PROXIMAL HUMERUS IN CONNECTION WITH MORE RETROVERSION AND INCREASE STABILITY WITH THE HELP OF THE REVERSE IMPLANTS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551819 EQUINOXE LARGE PROX BODY +0 KWT EXACTECH, INC. UNK UNK 10885862268129

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R