BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 58MM CUP NON FLARED

    MDR report key: 7213120 · Received January 23, 2018

    Report

    Report Number
    0001825034-2018-00393
    Event Type
    Injury
    Date Received
    January 23, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 15-106058, M2A-38 58 MM CUP NON FLARED, 427140. X11-180314, BI-METRIC/X POR NC LAT 14X150, 333790. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2018-00392, 0001825034-2018-00394.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS BEING CONSIDERED FOR A REVISION PROCEDURE DUE TO UNKNOWN REASONS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57146 M2A-38 58MM CUP NON FLARED PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 427140

    Patients

    Seq Age Sex Outcome Treatment
    1 Other