BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 9341344 · Received November 19, 2019

    Report

    Report Number
    0001825034-2019-05238
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 24, 2019
    Report Date
    March 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 WAS REVIEWED AND NO DISCREPANCIES 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). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 15-105052 LOT NUMBER: 607040 BRAND NAME: M2A 1 PC SHELL 38MMX52MM. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05237. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING ELEVATED COBALT LEVELS APPROXIMATELY 10 YEARS POST IMPLANTATION. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136306 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 069820

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O