BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS LARGE FLANGE

    MDR report key: 7621112 · Received June 20, 2018

    Report

    Report Number
    0001825034-2018-04154
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    January 27, 2015
    Report Date
    June 20, 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: 211254, COMPR SRS 60MM DST HML BDY RT, 952960, 114817, DISC ULNA 3X115MM RT W/BRNG C, UNKNOWN, UNKNOWN, UNKNOWN DISCOVERY HUMERAL CONDYLE KIT, UNKNOWN, 211236, COMPR SRS MOD STEM - 8X100MM, 635430. 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. 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. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. THERE IS LIKELY OSTEOPENIA PRESENT. RADIOLUCENCY IS NOTED ALONG THE ULNAR COMPONENT WHICH IS SUGGESTIVE OF LOOSENING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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 - 04151, 0001825034 - 2018 - 04152, 0001825034 - 2018 - 04153, 0001825034 - 2018 - 04150.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY. DURING A ONE AND THREE YEAR FOLLOW UP APPOINTMENT, THE PATIENT EXPERIENCED MODERATE TO SEVERE PAIN, DIFFICULTY SLEEPING, MODERATE TINGLING, DIFFICULTY OPENING A JAR, DIFFICULTY DOING HEAVY CHORES, DIFFICULTY CARRYING A BAG, DIFFICULTY CUTTING, WASHING BACK, LIMITED IN SOCIAL ACTIVITIES, AND LIMITED/ UNABLE TO DO DAILY AND RECREATIONAL ACTIVITIES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460214 COMPR SRS LARGE FLANGE PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 916200

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other