BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE CAGE SCREW M, 35MM

    MDR report key: 16223368 · Received January 23, 2023

    Report

    Report Number
    1220246-2023-06153
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    December 7, 2022
    Report Date
    August 1, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT IS CONFIRMED BASED ON THE X-RAY PHOTOS THAT THE CUSTOMER PROVIDED, WHICH DISPLAY THE ECLIPSE GAGE SCREW IMPLANTED IN THE PATIENT, AND REPLACED PER THE PAIN AND CUFF DYSFUNCTION. HOWEVER, WITHOUT THE RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED OF A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. PATIENT UNDERWENT TOTAL SHOULDER PROCEDURE ON (B)(6) 2020, IN WHICH THE ARTHREX ECLIPSE IMPLANT SET WAS USED. A YEAR LATER, (B)(6) OF 2022, PATIENT PRESENTED PAIN AND CUFF DYSFUNCTION. A DECISION WAS MADE TO CONVERT THE ARTHROPLASTY PROCEDURE TO A REVERSE PROCEDURE ON (B)(6) 2022. THIS IS ALL THE INFORMATION PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 1/10/2023: DURING THE ORIGINAL SURGERY ON (B)(6) 2020, THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: ARTHREX ECLIPSE HUMERAL HEAD SIZE 41X16MM, PART NUMBER AR-9341-16, LOT1911007. ARTHREX ECLIPSE CAGE SCREW MEDIUM, PART NUMBER AR-9301-02, LOT 18.01106. ARTHREX ECLIPSE TRUNION 39MM, PART NUMBER AR-9301-39CPC LOT 18.01134. ARTHREX UNIVERS VAULT LOCK GLENOID SMALL, PART NUMBER AR-9106-01, LOT 1027261912. DURING THE REVISION SURGERY, THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: ARTHREX UNIVERS VAULT LOCK GLENOID SMALL, PART NUMBER AR-9106-01, LOT 1027261912. ARTHREX ECLIPSE HUMERAL HEAD SIZE 41X16MM, PART NUMBER AR-9341-16, LOT 1911007. ARTHREX ECLIPSE CAGE SCREW MEDIUM, PART NUMBER AR-9301-02, LOT 18.01106. DURING REVISION SURGERY, THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: MODULAR GLENOID CENTRAL POST, PART NUMBER AR-9561-25P, LOT 5436. MODULAR GLENOID BASEPLATE, PART NUMBER AR9590-24-2, LOT 14957770. NON-LOCKING SCREW, PART NUMBER AR9562-36N, LOT NUMBER 2021005155. LOCKING SCREW, PART NUMBER AR-9563-24, LOT 14991605. LOCKING SCREW, PART NUMBER AR-9536-16, LOT NUMBER 14964000. GLENOSPHERE, PART NUMBER AR9564-T2433-LAT, LOT NUMBER 20.03005. FACILITY REPRESENTATIVE HAS CORRECTED THE REVISION SURGERY DATE TO (B)(6) 2022. THERE WAS NO COMPLICATION WHILE PERFORMING REVISION SURGERY. BOTH THE ORIGINAL AND REVISION SURGERY TOOK PLACE AT THE SAME FACILITY AND WERE PERFORMED BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430783 ECLIPSE CAGE SCREW M, 35MM TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM 18.01106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other