BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 54MM

    MDR report key: 7664287 · Received July 5, 2018

    Report

    Report Number
    0001825034-2018-04438
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    June 14, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS. CONCOMITANT MEDICAL PRODUCTS: 11-173660, M2A 38MM MOD HD -6MM NK, 618140, 11-103206, TAPERLOC POR LAT FMRL 12.5X145, 944810. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2018-04437. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ANALYSIS OF PRODUCTION RECORDS, NO PROBLEM DETECTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED 13 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED METAL ION LEVELS. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506475 M2A-38 CUP NON FLARED SZ 54MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 492970

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R