BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE X-LINKED HYALUR 3ML

    MDR report key: 12159692 · Received July 13, 2021

    Report

    Report Number
    0001822565-2021-01923
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    May 25, 2021
    Report Date
    July 21, 2021
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT GEL ONE INJECTION APPROXIMATELY TWO (2) MONTHS AGO. PATIENT EXPERIENCED PAIN AFTER INJECTION AND DOCTOR GAVE HER A CORTISONE SHOT RIGHT AFTER TO ALLEVIATE THE PAIN. CORTISONE SHOT DID NOT HELP AND PATIENT HAS BEEN EXPERIENCING PAIN EVER SINCE. PATIENT CALLED APPROXIMATELY THREE (3) WEEKS AGO TO REPORT THAT HER PAIN HAD GOTTEN WORSE WITHIN THE PAST 48 HOURS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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 (7) WEEKS AGO. SUBSEQUENTLY, PATIENT HAS NOT EXPERIENCED RELIEF SINCE THE PROCEDURE, AND REPORTED AN INCREASE OF PAIN APPROXIMATELY FIVE (5) 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
    1053089 GEL-ONE X-LINKED HYALUR 3ML PROSTHESIS, BIOLOGICS MOZ SEIKAGAKU CORPORATION NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other