BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REV LOCKING SCREW

    MDR report key: 14843136 · Received June 28, 2022

    Report

    Report Number
    1038671-2022-00742
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    May 13, 2022
    Report Date
    April 19, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086495
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-31-36, 7129906 - GLENOSPHERE, 36MM, 320-35-01, 7180131 - SMALL GLENOID PLATE, 320-20-00, 7165747 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) SERIAL NUMBER: (B)(6), EXPIRATION DATE: 09-NOV-2026. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF NOT FULLY SEATING THE GLENOSPHERE ON THE BASEPLATE, POSSIBLY DUE TO INCOMPLETE REMOVAL OF AN OSTEOPHYTE ABOVE THE GLENOID, WHICH LED TO INCOMPLETE SEATING/CROSS-THREADING OF THE GLENOSPHERE LOCKING SCREW AT THE TIME OF IMPLANTATION. INCOMPLETE SEATING OF THE SCREW LIKELY ALLOWED THE SCREW TO BACK OUT OVERTIME AND CAUSED THE GLENOSPHERE TO BECOME LOOSE ON THE BASEPLATE. (H4) DEVICE MANUFACTURE DATE: 11-NOV-2021.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 MONTHS POSTOP THE INITIAL FRACTURE RSA, THE FEMALE PATIENT HAD COMPLAINED OF PAIN, THE SURGEON FOUND BY X-RAY THAT THE SCREW HAD BACKED OUT FROM THE APPROPRIATE POSITION. AS A RESULT, THE SURGEON DECIDED TO PERFORM REVISION SURGERY. THE LINER, GLENOSPHERE AND LOCKING SCREW ONLY WERE REPLACED. THE GLENOID PLATE WAS NOT REPLACED DUE TO THE ASSEMBLY CONDITION BETWEEN GLENOID BASE PLATE AND LOCKING SCREW THAT USED AT PRIMARY SURGERY WAS CONFIRMED AND IT WAS NOTED THAT THE LOCKING SCREW COULD NOT INSERT INTO THE HOLE OF THE GLENOID BASE PLATE CORRECTLY. BASED ON THE THIS, A NEW LOCKING SCREW WAS TRIED AND COULD BE INSERTED INTO THE HOLE OF GLENOID BASE PLATE THAT WAS USED BY PRIMARY SURGERY CORRECTLY. THE SURGEON DID NOTE THAT DURING THE PRIMARY RSA, WHEN HE PLACED THE GLENOSPHERE, HE FOUND AN OSTEOPHYTE ABOVE THE GLENOID, AND REMOVED IT. HE NOTED THIS STEP MAY HAVE AFFECTED THE PLACEMENT/SEATING OF THE GLENOSPHERE FULLY. THE LOCKING SCREW WAS NOTED TO HAVE FULLY COME OFF, SO THE REMOVAL PROCEDURE OF IMPLANTS WAS EASY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043260 EQ REV LOCKING SCREW PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-15-05 UNK 10885862086495

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10