BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBCHONDROPLASTY FOOT & ANKLE KIT 3CC SIDE 11GA X 120MM

    MDR report key: 12729668 · Received November 1, 2021

    Report

    Report Number
    3008812173-2021-00004
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    April 1, 2021
    Report Date
    November 30, 2021
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    UDI-DI
    00889024205338
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS IDENTIFIED THAT THE PATIENT'S AVASCULAR NECROSIS DEVELOPED PRIOR TO THE SUBCHONDROPLASTY PROCEDURE AND DID NOT WORSEN FOLLOWING THE PROCEDURE. AS THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY AND THERE HAVE BEEN NO ALLEGATIONS AGAINST THE DEVICE, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE DEFINITION OF A COMPLAINT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS USED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AVASCULAR NECROSIS APPROXIMATELY FOUR (4) TO FIVE (5) MONTHS FOLLOWING A LEFT ANKLE SUBCHONDROPLASTY INJECTION. THE PATIENT IS BEING TREATED WITH A BRACE AND CONTINUES TO EXPERIENCE PAIN, STIFFNESS AND DIFFICULTY WITH ACTIVITIES, TOLERATING WITH STEROID THERAPY. STUDY NOTES DID NOT NOTE ANY ABNORMALITIES OR COMPLICATIONS DURING THE INJECTION OF THE SUBCHONDROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628751 SUBCHONDROPLASTY FOOT & ANKLE KIT 3CC SIDE 11GA X 120MM FILLER, BONE OJH ZIMMER KNEE CREATIONS, INC. N/A KC06917 00889024205338

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other