BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT R 1X40 US

    MDR report key: 14593721 · Received June 3, 2022

    Report

    Report Number
    3006946279-2022-00053
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868214578
    PMA / PMN Number
    K172408
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL DEVICE: OXF UNI TIB TRAY SZ B LM PMA; ITEM# 154720; LOT# 783570. OXF ANAT BRG LT SM SIZE 3 PMA; ITEM#159540; LOT#075460. OXF TWIN-PEG CMNTD FEM SM PMA; ITEM#161468; LOT#953870. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT WAS NOT RETURNED OR PICTURES NOT PROVIDED. DEVICE EVALUATION COULD NOT BE PERFORMED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO THE LOOSENING OF THE TIBIAL TRAY AND PAIN IN THE LEFT KNEE, APPROXIMATELY ONE YEAR POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555834 BIOMET BONE CEMENT R 1X40 US BONE CEMENT LOD BIOMET FRANCE S.A.R.L. N/A 005FAE2408 00887868214578

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H