BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE SRS FLANGE

    MDR report key: 7621095 · Received June 20, 2018

    Report

    Report Number
    0001825034-2018-04145
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    April 18, 2016
    Report Date
    June 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    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 3X155MM LT W/BRNG C, 869410, 211250, COMPR SRS 50MM DST HML BDY LT, 430570, UNKNOWN, UNKNOWN COMPREHENSIVE SRS MOD STEM, UNKNOWN, UNKNOWN, UNKNOWN DISCOVERY HUMERAL CONDYLE KIT, UNKNOWN. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN THE (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS OF THE DEVICE INVOLVED IN THE EVENT ARE UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01623, 0001825034 - 2018 - 04143, 0001825034 - 2018 - 04144, 0001825034 - 2018 - 04146. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. PRODUCT LOCATION UNKNOWN.

    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
    465135 UNKNOWN COMPREHENSIVE SRS FLANGE PROSTHESIS, ELBOW JDC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other