BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X38MM

    MDR report key: 18958269 · Received March 22, 2024

    Report

    Report Number
    0001822565-2024-00776
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 26, 2024
    Report Date
    April 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572676
    PMA / PMN Number
    K190656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO CONFIRM THE COMPLAINT AS NO PRODUCT INFORMATION OR MEDICAL RECORDS WERE PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00641. D10: UNKNOWN BIOMET SHELL CAT #: 650-1065 / CER OPTION TYPE 1 TPR SLEVE -3 / LOT #: 3101857. CAT #: 650-1055 / CER BIOLOXD OPTION HD 28MM / LOT #: 3114759. 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 WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO UNKNOWN REASONS. A SHELL, BEARING, HEAD AND TAPER WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554141 VIVACIT-E DM BEARING 28X38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 65931510 00889024572676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10 NARRATIVE.