BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT R 1X40 US

    MDR report key: 15678441 · Received October 27, 2022

    Report

    Report Number
    3006946279-2022-00109
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    110035368
    PMA / PMN Number
    K172408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: E1 VNGD AS TIB BRG 12X67, ITEM#: EP-189042, LOT#013920. VG 360 UNIV PST FM AUG 67.5X5, ITEM#: 185345, LOT#793090. VG 360 DST FM AG 67.5X5 LL/RM, ITEM#: 185325, LOT#901770. VANGUARD CR ILOK FEM-RT 67.5, ITEM#: 183010, LOT#J7125799. VG 360 DST FM AG 67.5X5 RL/LM, ITEM#: 185305, LOT#364420. 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EXPLANTED AND DISCARDED SO NO DEVICE EVALUATION COULD BE PERFORMED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE REVIEW OF THE STERILIZATION CERTIFICATE INDICATES THAT THE PRODUCTS WERE STERILIZED ACCORDING TO THE SPECIFICATION. THIS DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THAT THE PATIENT UNDERWENT INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT A TWO-STAGE REVISION OPERATION DUE TO INFECTION. THE SURGEON REMOVED THE CR FEMUR AND CEMENTED POLY AND REPLACED IT WITH FULL KNEE REVISION COMPONENTS. 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
    2558368 BIOMET BONE CEMENT R 1X40 US BONE CEMENT LOD BIOMET FRANCE S.A.R.L. N/A AY35BI0606 110035368

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R