BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE X-LINKED HYALUR 3ML

    MDR report key: 13831753 · Received March 20, 2022

    Report

    Report Number
    0001822565-2022-00786
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    December 7, 2021
    Report Date
    March 18, 2022
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT DEVICE CODE - MOZ. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT 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 · 0

    IT WAS REPORTED A PATIENT RECEIVED A GEL-ONE INJECTION APPROXIMATELY THREE (3) MONTHS AGO. THE DAY AFTER THE INJECTION, THE PATIENT STARTED EXPERIENCING PAIN, SWELLING, AND THE FORMATION OF LUMPS BELOW THE KNEE. PATIENT PLANS ON SEEING HER DOCTOR LATER THIS MONTH FOR FURTHER EVALUATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523944 GEL-ONE X-LINKED HYALUR 3ML INJECTION, BIOLOGICS MOZ SEIKAGAKU CORPORATION NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other