BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, MEDIUM

    MDR report key: 8479668 · Received April 3, 2019

    Report

    Report Number
    1220246-2019-00997
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 13, 2019
    Report Date
    May 31, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057326
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS REQUESTED/IS EXPECTED BUT HAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. VISUAL EVALUATION REVEALED THE GLENOID WAS FOUND TO BE DAMAGED AND/OR WORN. THE OUTSIDE SURFACE (PEG SIDE), SHOWED THE SUPERIOR AND CENTRAL PEGS WITH NO TRACE OF CEMENT, AND THE INFERIOR PEG WITH A SMALL AMOUNT OF CEMENT. THE ABSENCE OF CEMENT IS THE MOST LIKELY CAUSE OF LOOSENING OF THE GLENOID PLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A REVISION REVERS TOTAL SHOULDER PROCEDURE THE FOLLOWING ARTHREX PART AND LOT NUMBERS WERE EXPLANTED: AR-9105-02, LOT: 1516009, QTY.: 1; AR-9345-19, LOT: 1295114100, QTY.: 1; AR-9301-02, LOT: 2501224206, QTY.: 1. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2019. THE REP STATED THE REASON FOR THE REVISION WAS DUE TO A DRASTIC CHANGE IN THE GLENOID SINCE HAVING THE DEVICES IMPLANTED DURING THE ORIGINAL PROCEDURE THAT TOOK PLACE ON (B)(6) 2015. THE REP STATED THE GLENOID COMPONENT BECAME LOOSE DUE TO THE CHANGES IN THE GLENOID. ONCE ALL COMPONENTS WERE EXPLANTED, THE SURGEON DETERMINED THAT THE DEFECT ON THE GLENOID WAS SEVERE. THE SURGEON DECIDED TO BONE GRAFT THE GLENOID AND PERFORM A HEMI TOTAL SHOULDER. X-RAYS HAVE BEEN PROVIDED, AND THE REP STATED THE EXPLANTED IMPLANTS WILL BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THE REP CONFIRMED THE ORIGINAL AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE ORIGINAL PROCEDURE WAS A FDA CASE STUDY FOR THE TOTAL SHOULDER ECLIPSE. THE REP WAS ONLY PRESENT FOR THE REVISION PROCEDURE. THE PATIENT EXPERIENCED SEVERE PAIN FROM GLENOID LOOSENING. THE SEVER DEFECT IN THE GLENOID PREVENTED THE SURGEON FROM PUTTING A NEW IMPLANT IN. IT IS UNKNOWN WHAT CAUSED THE CHANGES IN THE GLENOID. THE QUALITY OF THE BONE WAS SOFT. THE PATIENT WAS REVISED WITH A HEMI TOTAL SHOULDER WITH REVERS STEM AND CUP. THE SUBJECT WAS EXPLANTED AFTER THE STUDY HAD BEEN COMPLETED. THE FOLLOWING ARTHREX PART AND LOT NUMBERS WERE IMPLANTED DURING THE REVISION SURGERY: AR-9501-09P, LOT: 170063703; AR-9502F-36CPC, LOT: 18.00745; AR-9502-36ARCA, LOT: 261524; AR-9544-17RCA, LOT: 10039397.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273615 GLENOID, PE WITH PEG, MEDIUM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. GLENOID, PE WITH PEG, MEDIUM 1516009 00888867057326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other