BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE X-LINKED HYALUR 3ML

    MDR report key: 12153416 · Received July 12, 2021

    Report

    Report Number
    0001825034-2021-02061
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    May 25, 2021
    Report Date
    July 13, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MOZ
    PMA / PMN Number
    P080020
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DEVICE CODE - MOZ. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GEL-ONE INJECTION APPROXIMATELY SEVEN WEEKS AGO. SUBSEQUENTLY, PATIENT HAS NOT EXPERIENCED RELIEF SINCE THE PROCEDURE, AND REPORTED AN INCREASE OF PAIN APPROXIMATELY FIVE WEEKS POST-INJECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052726 GEL-ONE X-LINKED HYALUR 3ML PROSTHESIS, BIOLOGICS MOZ ZIMMER BIOMET, INC. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other