BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR FINNED STEM DIA .15MM

    MDR report key: 3802891 · Received April 23, 2014

    Report

    Report Number
    3008021110-2014-00008
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 26, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR OF ALL THE COMPONENTS EXPLANTED; WE VERIFIED THAT ALL OF THEM WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET BY LIMACORPORATE, THEREFORE, WE DON'T BELIEVE THAT THE DEVICE THEMSELVES ARE THE CAUSE OF THE INFECTION. THE EXPLANTS ARE NO AVAILABLE, BUT WE HAVE ASKED FOR MORE INFORMATION TO THE COMPLAINT SOURCE (E.G. X-RAYS RELATED TO THE 2 SURGERIES, DATA ON PATIENT CLINICAL HISTORY, TYPE OF INFECTION SUFFERED AND DATE OF ONSET OF THE INFECTION, CONFIRMATION THAT THE PROSTHESIS COMPONENTS WERE WELL FIXED ONE EACH OTHER AT THE TIME OF REVISION). WE WILL SUBMIT A FOLLOW-UP REPORT AFTER RECEIVING THIS INFORMATION.

    Description of Event or Problem · 1

    THIS IS A REVISION SURGERY DUE TO SEPTIC MOBILIZATION OF A SMR ANATOMIC HEMI PROSTHESIS, OCCURRED IN (B)(6). THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2012. THE WHOLE PROSTHESIS WAS REMOVED ON (B)(6) 2014 AND AN ANTIBIOTIC CEMENT SPACER WAS IMPLANTED. THE PLAN WAS TO CONVERT THE HEMI TO A REVERSE DUE TO PROGRESSION OF DISEASE AND ROTATOR CUFF TEAR. INTRA-OPERATIVE, IT COULD BE SEEN THAT THE IMPLANT APPEARED TO BE RETROVERTED BY MORE THAN 60, AND WAS COMPLETELY LOOSE. THERE WAS NO OSSEOINTEGRATION OF BONE ONTO THE STEM. IN ADDITIONAL PATIENT FELL OVER ONTO HER SHOULDER A YEAR AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245019 SMR FINNED STEM DIA .15MM KWT LIMACORPORATE S.P.A. 1304.15.150 201109652-1200012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ADAPTOR TAPER: MODEL # 1330.15.270| HUMERAL BODY: MODEL # 1350.15.010| HUMERAL HEAD: MODEL # 1322.09.440