BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 7798168 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08293
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    February 21, 2017
    Report Date
    August 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE REVISION NOTES IDENTIFIED EBL 100ML, LARGE AMOUNT OF METAL STAINED TISSUE NOTED CONSISTENT WITH METALLOSIS. FLUID SWABBED AND SENT FOR CULTURE, NO CORROSION NOTED ON THE TAPER OR HEAD. ADDITIONAL INFORMATION PROVIDED DID NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORDS (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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO UNKNOWN PRODUCT LOCATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE (B)(4) , M2A-MAGNUM PF CUP 52ODX46ID, 978330; 139252, M2A-MAGNUM 42-50MM TPR INSRT-6, 425220; 192510, ECHO POR FEM RED LAT NC 10X130, 991120. REPORT SOURCE, CONSUMER - ATTORNEY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION SURGERY APPROXIMATELY 6.5 YEARS POST IMPLANTATION DUE TO PAIN, PSEUDOTUMOR, AND METALLOSIS. IT WAS NOTED DURING THE REVISION SURGERY THAT A LARGE AMOUNT OF METAL STAINED TISSUE WAS PRESENT, ALONG WITH A MURKY FLUID. SURGEON NOTED THE BURSA WAS INCREDIBLY IRRITATED AND STAINED WITH METAL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637838 M2A-MAGNUM MOD HD SZ 46MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 405250

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R