BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCHONDROPLASTY

    MDR report key: 8199650 · Received December 27, 2018

    Report

    Report Number
    3008812173-2018-00042
    Event Type
    Injury
    Date Received
    December 27, 2018
    Date of Event
    September 17, 2018
    Report Date
    January 23, 2019
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL SUBJECT UNDERWENT SCP SURGERY ON (B)(6) 2017. CORTICOSTEROID INJECTIONS WERE GIVEN TO THE SUBJECT ON (B)(6) 2017. ON (B)(6) 2018, THE SUBJECT PROGRESSED TO A TOTAL KNEE REPLACEMENT. THE DEVICE WAS NOT RETURNED FOR THE INVESTIGATION, AS IT REMAINS IMPLANTED IN THE PATIENT. IN AN EFFORT TO BE CONSERVATIVE, THIS COMPLAINT WILL BE TREATED AS A SERIOUS INJURY AND WILL BE INVESTIGATED FURTHER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ON JANUARY 17TH, 2019, AN ADVERSE EVENT FORM FOR THE EVENT WAS RECEIVED FROM THE CLINICAL PROJECT LEAD STATING THAT THE RESPONSIBLE HEALTH CARE PROFESSIONAL FOR THE EVENT DETERMINED THE TKA WAS NOT RELATED TO THE PROCEDURE OR PROCESS.

    Description of Event or Problem · 1

    CLINICAL SUBJECT (B)(6) UNDERWENT TKA AFTER SCP.

    Description of Event or Problem · 1

    CLINICAL SUBJECT (B)(6) UNDERWENT TKA AFTER SCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037952 SUBCHONDROPLASTY SCP KIT OJH ZIMMER KNEE CREATIONS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other