BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, POLY WITH KEEL, LARGE

    MDR report key: 8887273 · Received August 13, 2019

    Report

    Report Number
    1220246-2019-01244
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 13, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057302
    PMA / PMN Number
    K010124
    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 THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019 WHERE THE GLENOID POLY W/ KEEL, AR-9104-03, WAS EXPLANTED. THE PATIENT SUFFERED A ROTATOR CUFF TEAR HOWEVER, THE FAILURE IS NOT RELATED TO THE IMPLANT. THE FOLLOWING WAS ALSO IMPLANTED: IDE-AR-9300-49CPC / LOT: 150070712; IDE-AR-9301-03 / LOT: 160109817; IDE-AR-9349-20 / LOT: 1706002. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: AFTER THE ORIGINAL PROCEDURE, THE PATIENT PRESENTED WITH PAIN AND LIMITED RANGE OF MOTION. AN MRI WAS ORDERED AND UNCOVERED A ROTATOR CUFF TEAR. THE REVISION WAS PERFORMED AT THE SAME FACILITY WITH THE SAME SURGEON AS THE FIRST SURGERY. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE REVISION: AR-9560-28-4 / LOT: 5662; AR-9561-35S / LOT: 5690; AR-9564-2842-LAT / LOT: 18.01739; AR-9563-28 / LOT: 2019000055 X3; AR-9563-28 / LOT: 2018035253; AR-9501-13S / LOT: 18.00400; AR-9502F-42CPC / LOT: 18.01658; AR-9503L-06 / LOT: 19.00081. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE DATE OF THE FIRST SURGERY WAS (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684218 GLENOID, POLY WITH KEEL, LARGE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. GLENOID, POLY WITH KEEL, LARGE 160042815 00888867057302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other