BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 46MM HUMERAL LINER +0

    MDR report key: 13769965 · Received March 15, 2022

    Report

    Report Number
    1038671-2022-00257
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 21, 2022
    Report Date
    August 17, 2022
    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

    (D4) CATALOG NUMBER: 320-46-00, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 02-MAR-2019, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G4) PMA/510(K)NUMBER: K063569. (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF EITHER INCOMPLETE SEATING OF THE HUMERAL LINER, HUMERAL TRAY, AND/OR TORQUE SCREW DURING IMPLANTATION, BONE IMPINGEMENT, PATIENT-RELATED CONDITIONS SUCH AS HIGH BMI, BACKSIDE WEAR, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO HUMERAL LINER DISASSOCIATION. (H4) DEVICE MANUFACTURE DATE: 04-MAR-2014 SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: EQUINOXE REVERSE 46MM HUMERAL LINER +0 D2B) COMMON DEVICE NAME: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED (D10) CONCOMITANT DEVICE(S): 300-01-15, 3891212 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM, 320-10-00, 4023807 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-20-00, 4029229 - EQ REVERSE TORQUE DEFINING SCREW KIT. (H6) COMPONENT CODE: 4755; PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 320-10-00, 66378004 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 15MM STEM - S/L 03113741.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS (B)(6) MALE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO HIS HUMERAL LINER BECOMING DISASSOCIATED FROM THE HUMERAL TRAY SOMETIME AFTER PRIMARY SURGERY. SURGEON REMOVED THE STEM, TRAY, AND LINER. DATE OF REVISION IS UNKNOWN AND INITIAL IMPLANT DATE IS UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38704 EQUINOXE REVERSE 46MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-46-00 UNK 10885862086730

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R SEE H10.