BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID, PE WITH PEG, SMALL

    MDR report key: 11612657 · Received April 5, 2021

    Report

    Report Number
    1220246-2021-02832
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    October 28, 2021
    Product Code
    KWS
    UDI-DI
    00888867057319
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED, LIGHT DAMAGE WAS OBSERVED ON THE TEETH OF THE PEGS AND KEEL AND ALONG THE EDGES OF THE DEVICE, BUT NO ABNORMALITIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE EVENT. BONE CEMENT WAS OBSERVED ON THE CENTRAL PEG AND ON THE KEEL.

    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 A GLENOID COMPONENT REMOVAL HAD TO BE PERFORMED AS A REVISION SURGERY DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. NO FURTHER INFORMATION RECEIVED. UPDATE 31-MAR-2021: FURTHER INFORMATION WAS RECEIVED. X-RAYS AND PICTURES WERE PROVIDED CONTAINING THE PART- AND LOT-NO. OF ALL INVOLVED DEVICES (AR-9105-01/LOT 1246018, AR-9301-02/LOT 2501252307, AR-9300-41CPC/LOT 2501241206, CD-9341-16/1242003), WHICH WERE PRIMARY IMPLANTED ON THE (B)(6) 2013. THE DATE OF INCIDENT WAS CONFIRMED TO BE THE (B)(6) 2021 ALTHOUGH THE PATIENT HAS EXPERIENCED THE CORRESPONDINGLY LARGE BURDEN ON HER SHOULDERS ALREADY FOR MANY YEARS, BUT HAD TO CARE FOR HER SEVERELY DISABLED HUSBAND. AFTER THE HUSBAND PASSED AWAY, THE PATIENT DECIDED TO HAVE THE OPERATION. DURING THE REVISION A FILLING WITH BONE SUBSTITUTE CERAMENT (HEMI) WAS PERFORMED TO TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512316 GLENOID, PE WITH PEG, SMALL PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS GLENOID, PE WITH PEG, SMALL 1246018 00888867057319

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other