BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS REVERS SPACER 36+15MM

    MDR report key: 10746465 · Received October 28, 2020

    Report

    Report Number
    1220246-2020-02269
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    June 8, 2015
    Report Date
    October 28, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867062504
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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 THAT DUE TO A METALLOSIS THE SHOULDER AND THE ARM OF THE PATIENT TURNED BLACK. THE SURGERY WHICH LED TO THE REPORTED EVENT WAS A SHOULDER PROSTHESIS WHICH WAS PERFORMED ON (B)(6) 2015. ACCORDING TO THE CUSTOMER ARTHREX DEVICES WERE IMPLANTED DURING THE INITIAL SURGERY IN 2015. CURRENTLY IT IS NOT KNOWN IN WHICH HOSPITAL THE INITIAL SURGERY TOOK PLACE. THEREFORE NO FURTHER INFORMATION ABOUT THE DETAILED INCIDENT AND THE USED ARTHREX PART NUMBERS ARE CURRENTLY AVAILABLE. UPDATE 12-OCT-2020: INITIALLY THE LOT NUMBERS WHICH WERE AFFECTED WERE NOT PROVIDED HOWEVER FURTHER INFORMATION WERE NOW PROVIDED THAT THE FOLLOWING PARTS WERE USED DURING THE INITIAL SURGERY 2015: AR-9120-01, LOT: 140113110. AR-9145-30, LOT: 140123108. AR-9504S-04, LOT: 2501212801. AR 9165-15, LOT: 140103207. AR-9145-30, LOT: 2501417704. AR-9502-36CPC, LOT: 140120310. AR -9501-07CPC, LOT: 2501215303. AR-9503S-03, LOT: 140104307. AR-9555-15, LOT:2501215101. AR-7213, LOT: 12812. AR-7200, LOT: 12795. HOWEVER IT COULD NOT BE CONFIRMED WHICH DEVICE HAS LED TO THE REPORTED ISSUE AND IF THE DEVICES ARE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210384 UNIVERS REVERS SPACER 36+15MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERS REVERS SPACER 36+15MM 2501215101 00888867062504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other