BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS 50MM DST HML BDY LT

    MDR report key: 7616128 · Received June 19, 2018

    Report

    Report Number
    0001825034-2018-01623
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    April 18, 2016
    Report Date
    March 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 114818, DISC ULNA 3 X 155 MM LT W/BRNG C, 869410. UNKNOWN, UNKNOWN COMPREHENSIVE SRS MOD STEM, UNKNOWN. UNKNOWN, UNKNOWN COMPREHENSIVE SRS FLANGE, UNKNOWN. UNKNOWN, UNKNOWN DISCOVERY HUMERAL CONDYLE KIT, UNKNOWN. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. X-RAYS WERE SUBMITTED TO MMI FOR REVIEW. BONE QUALITY IS OSTEOPENIC. MULTIPLE IMAGES WHICH DEMONSTRATE PUNCTATE HYPERDENSITIES WITHIN THE SOFT TISSUES AT THE LEVEL OF THE ELBOW WHICH COULD SUGGEST METALLOSIS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. A POSSIBLE CONTRIBUTING FACTOR TO THE PAIN COULD BE THE METALLOSIS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04143, 0001825034 - 2018 - 04144, 0001825034 - 2018 - 04145, 0001825034 - 2018 - 04146.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REPORTED MODERATE DIFFICULTY SLEEPING DUE TO PAIN, BEING UNABLE TO DO HEAVY CHORES, TO CARRY A BAG, TO WASH BACK, TO CUT, TO DO RECREATIONAL ACTIVITIES, AND EXTREMELY LIMITED WITH DAILY ACTIVITIES. PATIENT ALSO INDICATED DURING THE 6 MONTH FOLLOW UP MODERATE ARM, SHOULDER, OR HAND PAIN, AND NO PAIN AT THE ONE YEAR FOLLOW UP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456673 COMPR SRS 50MM DST HML BDY LT PROSTHESIS, ELBOW KWT ZIMMER BIOMET, INC. N/A 430570

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other