BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 9225784 · Received October 23, 2019

    Report

    Report Number
    0001825034-2019-04740
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    May 13, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOMET CUP CAT#US157852 LOT#151290 BIOMET TAPER CAT#139254 LOT#844730, BIOMET MOD HEAD CAT#157446 LOT#843560, BIOMET STEM CAT#11-103204 LOT#939100.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER ADAPTER WAS DETERMINED TO BE NOT REPORTABLE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER ADAPTER WAS DETERMINED TO BE NOT REPORTABLE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04741.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 10 YEARS LATER DUE TO METALLOSIS. IT WAS NOTED THE BLOOD SERUM COBALT AND CHROMIUM LEVELS WERE ELEVATED. DURING REVISION NON PURULENT SEROUS FLUID AND DISCOLORED TISSUE WAS NOTED IN THE HIP SPACE.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019121 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 844730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNK HEAD CAT#NI LOT#NI| UNK LINER CAT#NI LOT#NI| UNK STEM CAT#NI LOT#NI| UNK HEAD CAT#NI LOT#NI| UNK LINER CAT#NI LOT#NI| UNK STEM CAT#NI LOT#NI