BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5X28MM PERIPHERAL SCREW, NON-LOCKING

    MDR report key: 11730998 · Received April 27, 2021

    Report

    Report Number
    1220246-2021-02982
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 27, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296695
    PMA / PMN Number
    K173900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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 THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN INFECTION AFTER UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE CAUSING THE NEED FOR IMPLANT REMOVAL. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY AND TOOK PLACE AT THE SAME FACILITY AS THE ORIGINAL SURGERY. THE REVISION TOOK PLACE ON (B)(6) 2021. THE PART AND LOT NUMBERS OF EXPLANTED ARTHREX MATERIAL IS CURRENTLY UNKNOWN. THE PATIENT WAS REVISED WITH HEMI-ARTHROPLASTY, USING ARTHREX APEX. ADDITIONAL INFORMATION RECEIVED ON 4/9/2021: THE REP PROVIDED THE PART/LOT NUMBERS OF EXPLANTED ARTHREX PRODUCT THAT WAS REMOVED DURING THE REVISION SURGERY. SEE EXPLANTED MATERIAL LISTED BELOW; AR-9561-25P / LOT: 8013, AR-9560-28-4 / LOT: 6807, AR-9501-06S / LOT: 19.03511, AR-9502F-39LCPC / LOT: 19.02275, AR-9564-2839-LAT / LOT: 19.01015, AR-9564-2839 / LOT: 19.00603, AR-9562-28NL / LOT: 18.00143, AR-9503M-03 / LOT: 18.01724, AR-9505-06 / LOT: 19.03720, AR-9563-28 / LOT: 2019003486 (X 2), AR-9562-28NL / LOT: 2019001689.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630989 4.5X28MM PERIPHERAL SCREW, NON-LOCKING SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. 4.5X28MM PERIPHERAL SCREW, NON-LOCKING 18.00143 00888867296695

    Patients

    Seq Age Sex Outcome Treatment
    1 Other