BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY,

    MDR report key: 4945064 · Received July 28, 2015

    Report

    Report Number
    3008021110-2015-00029
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 30, 2015
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE MANUFACTURING CHART OF THE LOT # OF STEM AND REVERSE HUMERAL BODY INVOLVED ((B)(4)) WITHOUT FINDING ANY ANOMALY. A TOTAL OF (B)(4) STEMS AND (B)(4) REVERSE BODIES WERE MANUFACTURED WITH THE ABOVE LOT #, AND THIS IS THE ONLY COMPLAINT RECEIVED ON THESE LOT #. NO X-RAYS ARE AVAILABLE, THEREFORE A RADIOLOGIC EVALUATION IS NOT POSSIBLE. WE RECEIVED THE EXPLANTS AND WE COULD ANALYSE THEM. A DIMENSIONAL CHECK OF THE MALE TAPER (STEM) AND FEMALE TAPER (REVERSE BODY) CONFIRMED THE ABSENCE OF ANY DIMENSIONAL ANOMALY ON THEM. THE LOCKING SCREW HAS THE THREAD STRIPPED; THIS IS MOST LIKELY DUE TO THE USE OF THE SCREW "IN VIVO", AS IT APPEARS THAT THE SCREW WAS TIGHTENED OVER THE REVERSE BODY WITHOUT ANY PROBLEM AT THE TIME OF ORIGINAL SURGERY (2011). WE PERFORMED A FUNCTIONAL TEST WITH ANOTHER (FUNCTIONING) SCREW AND THE EXPLANTED STEM AND REVERSE BODY: THE TWO DEVICES WERE ASSEMBLED AS PER SURGICAL TECHNIQUE, THEN THE LOCKING SCREW WAS TIGHTENED ON THE REVERSE BODY TO FINALIZE THE COUPLING. NO LOOSENING BETWEEN THE TWO DEVICES WAS NOTICED AFTER THIS OPERATION, THE COUPLING WAS ABSOLUTELY STABLE. BASED ON THE ABOVE ANALYSIS, WE BELIEVE THAT THE DEVICES COULD PERFORM WELL "IN VIVO". BY THE INFO REPORTED, PATIENT STARTED USING CRATCHES APPROX 6 MONTHS BEFORE THE REVISION, AND STARTED FEELING DISCOMFORT IN HER SHOULDER WHEN USING CRATCHES; IT'S POSSIBLE THAT THE USE OF THE CRATCHES CREATED A SORT OF "LEVER EFFECT" ON THE PROSTHESIS OVER TIME, AND THIS CONTRIBUTED TO THE LOOSENING BETWEEN REVERSE BODY AND STEM MALE TAPER. WE ALSO BELIEVE THAT SUCH LOOSENING CANNOT OCCUR (ALSO WITH THE USE OF CRATCHES) IF THE DEVICES ARE FIRMLY FIXED AND THE LOCKING SCREW IS CORRECTLY TIGHTENED ON THE REVERSE BODY. THIS IS THE 2ND COMPLAINT REPORTED ABOUT THE POST-OP LOOSENING BETWEEN A SMR STEM AND A REVERSE HUMERAL BODY, GIVING A SPECIFIC REVISION RATE WHICH IS VERY LOW ((B)(4)). IN ADDITION, ACCORDING TO OUR ANALYSIS, BOTH CASES WERE NOT DUE TO A MALFUNCTION OF THE DEVICES. NO CORRECTIVE ACTIONS HAVE BEEN DEFINED FOR THIS CASE, THAT APPEAR TO BE NOT PRODUCT-RELATED. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 1

    THE SMR REVERSE PROSTHESIS WAS IMPLANTED IN (B)(6) 2011 (EXACT DATE UNKNOWN). ACCORDING TO THE INFO REPORTED, THE REVERSE HUMERAL BODY CAME LOOSE FROM THE STEM OVER TIME, LEADING TO A REVISION SURGERY ON (B)(6) 2015. PATIENT HAD BEEN USING CRUTCHES TO WALK FOR THE 6 MONTHS BEFORE THE REVISION; ACCORDING TO THE COMPLAINT SOURCE THIS MAY HAVE CONTRIBUTED TO THE LOOSENING BETWEEN STEM AND REVERSE BODY (ALTERED FORCES ON THE SHOULDER JOINT). ANOTHER SMR REVERSE WAS IMPLANTED ON (B)(6) 2015 (SURGEON REPLACED STEM, REVERSE BODY + SCREW AND REVERSE LINER). THE EVENT OCCURRED IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489211 SMR REVERSE HUMERAL BODY, HSD-KWS HSD LIMACORPORATE S.P.A. 1352.15.010 201010230

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention