BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCONDROPLASTY

    MDR report key: 7027545 · Received November 14, 2017

    Report

    Report Number
    3008812173-2017-00025
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    October 5, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON JANUARY 3RD, AN UPDATED ADVERSE EVENT REPORT WAS RECEIVED STATING THAT THE ADVERSE EVENT WAS NOT RELATED TO THE PROCEDURE. THEREFORE THE EVENT IS NO LONGER CLASSIFIED AS A SERIOUS INJURY OR REPORTABLE EVENT.

    Description of Event or Problem · 1

    PATIENT RECV'D TKA AFTER SCP.

    Description of Event or Problem · 1

    PATIENT RECVD TKA AFTER SCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808278 SUBCONDROPLASTY SUBCONDROPLASTY OJH ZIMMER KNEE CREATIONS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR