BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 7804313 · Received August 22, 2018

    Report

    Report Number
    0001825034-2018-08299
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    February 12, 2018
    Report Date
    October 5, 2018
    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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO REMAINING IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCT(S): EP-200152, ACT ARTIC E1 HIP BRG 28X46MM, 902310; 192510, ECHO POR FEM RED LAT NC 10X130, 433550; 650-1065, CER OPTION TYPE 1 TPR SLEVE -3, 164940; 650-1055, CER BIOLOXD OPTION HD 28MM, 460910. REPORT SOURCE, CONSUMER - ATTORNEY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08300.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A CLOSED REDUCTION AFTER DISLOCATION 1 YEAR POST OPERATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648139 M2A-MAGNUM PF CUP 52ODX46ID HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 519160

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention