BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 8734964 · Received June 26, 2019

    Report

    Report Number
    3002806535-2019-00536
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 10, 2019
    Report Date
    November 20, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00880304521933
    PMA / PMN Number
    K141653
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. FOLLOWING VISUAL, DIMENSIONAL AND ASSEMBLY CHECKS OF THE RETURNED ITEMS, NO DISCREPANCIES HAVE BEEN IDENTIFIED, THEREFORE THE REPORTED EVENT HAS NOT BEEN CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 BY THE HOSPITAL THAT DURING A HIP REPLACEMENT PROCEDURE, THE IMPLANT WOULD NOT ASSEMBLE WITH MATING IMPLANT. SUBSEQUENTLY, ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT:CER OPTION TYPE 1 TPR SLEVE +6 CATALOG #: 650-1068 LOT #: 2953805. MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00537. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT DURING A HIP REPLACEMENT PROCEDURE, THE IMPLANT WOULD NOT ASSEMBLE WITH MATING IMPLANT. SUBSEQUENTLY, ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528763 CER BIOLOXD OPTION HD 40MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2957980 00880304521933

    Patients

    Seq Age Sex Outcome Treatment
    1