BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS APEX HUMERAL STEM, 12MM

    MDR report key: 10055609 · Received May 14, 2020

    Report

    Report Number
    1220246-2020-01834
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    February 26, 2020
    Report Date
    May 14, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867134706
    PMA / PMN Number
    K131633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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 VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD PREVIOUS SHOULDER PROCEDURE. THE PATIENT EXPERIENCED LOOSENING OF THE IMPLANT ON THE HUMERAL SIDE THAT WAS UNRELATED TO ANY TRAUMA. THE PATIENT UNDERWENT A REVISION TO A DIFFERENT TYPE OF ARTHROPLASTY. PATIENT IS ONGOING AND IMPROVING. NO FURTHER INFORMATION WAS PROVIDED FROM THE SURGICAL OUTCOME SYSTEM. FURTHER INVESTIGATION IS IN PROCESS. ADDITIONAL INFORMATION OBTAINED 4/14/20: PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY AND OPEN BICEPS TENOSIS PROCEDURE ON (B)(6) 2016. PATIENT BEGAN EXPERIENCING PAIN ISSUES IN (B)(6) 2018. ON (B)(6) 2020 THE SAME SURGEON PERFORMED A REVISION PROCEDURE AT THE SAME FACILITY. THE REVISION PROCEDURE WAS AN OPEN SURGERY, REVISION TO REVERSE REPLACEMENT. EXPLANTED PART NUMBERS ARE NOT YET KNOWN. PATIENT STUDY ID IS (B)(6). ADDITIONAL INFORMATION OBTAINED 4/22/20: THE FOLLOWING ARE THE IMPLANT PART NUMBERS FROM THE ORIGINAL (B)(6) 2016 PROCEDURE. ALL OF THE DEVICES LISTED WERE EXPLANTED DURING THE REVISION PROCEDURE ON (B)(6) 2020. THE DEVICE DISPOSITION IS UNKNOWN. AR-9106-03 UNIVERS VAULTLOCK GLENOID (LOT 1027261550}. AR-9150-19P UNIVERS II HUMERAL HEAD (LOT 150084918}. AR-9100-12S UNIVERS APEX HUMERAL STEM (LOT 10019413}.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519568 UNIVERS APEX HUMERAL STEM, 12MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 12MM 10019413 00888867134706

    Patients

    Seq Age Sex Outcome Treatment
    1 Other