BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS II HUMERAL STEM 8MM

    MDR report key: 10962178 · Received December 7, 2020

    Report

    Report Number
    1220246-2020-02395
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    March 13, 2009
    Report Date
    December 7, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867057081
    PMA / PMN Number
    K071032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 BY THE PATIENT THAT SHE UNDERWENT TOTAL JOINT REPLACEMENT IN HER SHOULDERS IN 2009 AND 2010. PATIENT IS CURRENTLY UNDER CARE FOR SYSTEMIC SCLEROSIS AND HAS BLOODWORK DONE EVERY 6 MONTHS. THE COBALT/CHROMIUM LEVEL IN HER BLOOD IS INCREASING. AT TIME OF INITIAL REPORT PART NUMBERS WERE NOT PROVIDED BUT HAVE BEEN REQUESTED. ADDITIONAL INFORMATION OBTAINED 11/17/20: THE PATIENT UNDERWENT RIGHT SHOULDER SURGERY (B)(6) 2009. PATIENT ALSO HAD LEFT SHOULDER SURGERY (B)(6) 2010 APPROXIMATELY ONE YEAR LATER THE PATIENT HAD A REVISION SURGERY ON THE LEFT SHOULDER BOTH THE (B)(6) 2010 SURGERY AND THE REVISION OF THAT SURGERY WERE DONE BY THE SAME SURGEON/FACILITY AS THE 2009 PROCEDURE. PATIENT IS UNSURE WHAT THE REVISION SURGERY ACTUALLY ENTAILED. PATIENT IS SEEING A RHEUMATOLOGIST FOR HER SYSTEMIC SCLEROSIS AND IT HAS BEEN DISCOVERED THAT SHE HAS COB ALT IN HER BLOOD. PATIENT WAS REFERRED TO HER PRIOR HIP REPLACEMENT SURGEON (DIFFERENT THAN SHOULDER SURGEON). MRI'S WEE PERFORMED AND SHOWED NO COMPROMISE. PATIENT BELIEVES THIS WAS PERFORMED APPROXIMATELY (B)(6) 2019. AT THIS TIME THEY DO NOT BELIEVE THAT ANY OF HER CURRENT HEALTH ISSUE ARE DUE TO THE COBALT ISSUE. THE CONCERN IS THAT THE COBALT ISSUE HAS INCREASED. THE PATIENT HAS REQUESTED AND HAS BEEN PROVIDED THE FULL MATERIAL COMPOSITION OF THE KNOWN ARTHREX DEVICES WHICH WERE IMPLANTED (B)(6) 2009. THE KNOWN ARTHREX PRODUCTS ARE AS FOLLOWS: AR-9104-01 (LOT 08.048) GLENOID, AR-9100-08P (LOT 0831002) UNIVERS HUMERAL STEM, AR-9144-17P (LOT 0830007) USP II HUMERAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427817 UNIVERS II HUMERAL STEM 8MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS II HUMERAL STEM 8MM 0831002 00888867057081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other