BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50M TPR INSRT +3

    MDR report key: 8063541 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10627
    Event Type
    Injury
    Date Received
    November 13, 2018
    Report Date
    December 4, 2018
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. THE HEAD COMPONENT WAS REMOVED AND REPLACED, WHILE THE CUP COMPONENT WAS FOUND TO BE WELL FIXED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE (B)(6) 2017. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN FEMORAL STEM; US157854 ¿ M2A MAGNUM CUP ¿ 790430; 157448 ¿ M2A MAGNUM HEAD ¿ 671350; THERAPY DATE: (B)(6) 2017. 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 -2018 -10626, 0001825034 -2018 -10629.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. 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
    903458 M2A-MAGNUM 42-50M TPR INSRT +3 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 916730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R