BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS REVERS GLENO 42 +4 LAT

    MDR report key: 9254829 · Received October 30, 2019

    Report

    Report Number
    1220246-2019-01379
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867061347
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE FACILITY IS NOT RELEASING THE DEVICE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PRIMARY REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2019. THE PATIENT RETURNED TO THE OR FOR A REVISION PROCEDURE ON (B)(6) 2019 DUE TO THE IMPLANTED GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE. DURING THE ORIGINAL PROCEDURE, THE CENTRAL SCREW DEPTH GAUGE WAS USED TO ENSURE THAT THE CENTRAL SCREW WAS FULLY SEATED. AFTER GLENOSPHERE IMPACTION, THE GLENOSPHERE FORCEPS WERE USED IN MULTIPLE PLANES TO ENSURE ENGAGEMENT OF THE MORSE TAPER. DURING THE REVISION PROCEDURE THE ORIGINAL GLENOSPHERE (AR-9120-02 / LOT: 18.01057) AND BASEPLATE (AR-9504L-04 / LOT: 18.00719) WERE EXPLANTED, AND THE SURGEON IMPLANTED A MGS BASEPLATE (AR-9560-28-2 / LOT: 5642) AND GLENOSPHERE (AR-9564-2842-LAT / LOT: 18.00802) IN ITS PLACE. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON, AND TOOK PLACE AT THE SAME FACILITY. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE: AR-9120-02 // LOT: 18.01057 // QTY.: 1. AR-9145-24 // LOT: 18.00674 // QTY.: 1. AR-9145-30 // LOT: 18.01275 // QTY.: 1. AR-9165-20NL // LOT: 10247862 // QTY.: 1. AR-9501-12P // LOT: 18.00906 // QTY/: 1. AR-9502F-42CPC // LOT: 160037703 // QTY.: 1. AR-9503L-03C // LOT: 150044008 // QTY.: 1. AR-9504L-04 // LOT: 18.00719 // QTY.: 1. AR-9550-06 // LOT: 18.00623 // QTY.: 1. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE REVISION PROCEDURE: AR-9503L-03C // LOT: 18.00561 // QTY.: 1. AR-9550-06 // LOT: 18.00990 // QTY.: 1. AR-9560-28-2 // LOT: 5642 // QTY.: 1. AR-9561-30S // LOT: 6227 // QTY.: 1. AR-9563-16 // LOT: 2019000253 // QTY.: 2. AR-9563-24 // LOT: 2019001686 // QTY.: 1. AR-9563-28 // LOT: 2019001343 // QTY.: 1. AR-9564-2842-LAT // LOT: 18.00802 // QTY.: 1. ADDITIONAL INFORMATION RECEIVED ON 10/08/219: THE REP REPORTED THE DISASSOCIATION WAS FIRST DISCOVERED FROM X-RAYS TAKEN DURING AN OFFICE VISIT ON (B)(6) 2019. THE REP IS FOLLOWING UP WITH THE SURGEON TO DISCUSS IF THE CAUSE OF THE DISASSOCIATION IS KNOWN. THE BONE QUALITY WAS HARD. THE REP STATED THE EXPLANTED DEVICES WERE SENT TO PATHOLOGY, AND WILL NOT BE RETURNING TO ARTHREX FOR EVALUATION. THE FOLLOWING LIST IS ALL OF THE ARTHREX PARTS THAT WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9120-02 // LOT: 18.01057, AR-9504L-04 // LOT: 18.00719, AR-9145-24 // LOT 18.00674, AR-9145-30 // LOT 18.01275, AR-9165-20NL // LOT 10247862, AR-9503L-03C // LOT 150044008, AR-9550-06 // LOT 18.00623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052101 UNIVERS REVERS GLENO 42 +4 LAT SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERS REVERS GLENO 42 +4 LAT 18.00719 00888867061347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other