BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 8339730 · Received February 14, 2019

    Report

    Report Number
    0001825034-2019-00558
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    November 2, 2018
    Report Date
    March 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE EVENT, IT HAS BEEN DETERMINED THAT THIS EVENT WAS A RESULT OF A COINCIDING PROCEDURE, AND WILL BE REPORTED UNDER MEDWATCH 0001825034-2019-00211. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: US157852 ¿ MAGNUM CUP ¿ 849260, 157446 ¿ MAGNUM HEAD ¿ 983620, 15-103203 ¿ TAPERLOC STEM ¿ 571490. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00554, 0001825034 - 2019 - 00556, 0001825034 - 2019 - 00557.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 7 YEARS POST IMPLANTATION. DURING THE PROCEDURE, THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 2800ML, WHICH REQUIRED A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132723 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 615460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R