BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCHONDROPLASTY

    MDR report key: 8105737 · Received November 27, 2018

    Report

    Report Number
    3008812173-2018-00039
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 30, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH THE INVESTIGATION, IT WAS DETERMINED THAT THE EVENT WAS A DUPLICATE THAT HAD BEEN PREVIOUSLY SUBMITTED UNDER REPORT NUMBER 3008812173-2018-00022-1. THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED SINCE THE LAST REPORT. PLEASE REFER TO THAT REPORT FOR INFORMATION REGARDING THE EVENT.

    Description of Event or Problem · 0

    PATIENT COMPLAINT VIA SOCIAL MEDIA.

    Additional Manufacturer Narrative · 1

    PATIENT REPORTED VIA SOCIAL MEDIA OF BONE NECROSIS OF DISTAL TIBIA AND PAIN POST SCP SURGERY; PICTURES OF THE X-RAYS WERE PROVIDED. LOT NUMBER OF DEVICE USED IS UNKNOWN. ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT REPORTED BONE NECROSIS AND PAIN VIA SOCIAL MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948051 SUBCHONDROPLASTY SCP KIT OJH ZIMMER KNEE CREATIONS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other