BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 8157325 · Received December 12, 2018

    Report

    Report Number
    0001825034-2018-11229
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    January 10, 2018
    Report Date
    January 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED AND REVIEWED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 157442, M2A-MAGNUM MOD HD, LOT # 861830, ITEM # 139254, M2A-MAGNUM 42-50MM TPR INSRT, LOT # 933320, ITEM # 103204, TAPERLOC POR FMRL, LOT # 841460.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, UPON REMOVING THE CUP, IT WAS NOTED THAT THERE WAS SOME DELAMINATION OF THE POROUS COATING THAT REMAINED SECURELY ATTACHED TO THE BONE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995958 M2A-MAGNUM PF CUP 48ODX42ID HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 613920

    Patients

    Seq Age Sex Outcome Treatment
    1