BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX52MM

    MDR report key: 8310013 · Received February 6, 2019

    Report

    Report Number
    0001825034-2019-00445
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    June 6, 2017
    Report Date
    February 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THIS REPORT IS A DUPLICATE OF 0001825034-2019-00003. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION REGARDING THIS EVENT IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED UNDER 0001825034-2019-00003.

    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: M2A 38MM MOD HD+6MM NK NO SKRT, PN 11-173664 LN UNKNOWN. ASSOCIATED: TAPERLOC BM/PC 10.0 X 140MM T1, PN 103204BM, LN UNKNOWN . REPORTING SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2019-00446.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED METALLOSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102705 M2A 1 PC SHELL 38MMX52MM PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R