BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE UHMWPE INSERT

    MDR report key: 6445035 · Received March 29, 2017

    Report

    Report Number
    3006946279-2017-00053
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    February 28, 2017
    Report Date
    June 8, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET US MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) K101336. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, ACCORDING TO AVAILABLE INFORMATION AND INVESTIGATION RESULTS, THIS EVENT IS DUE TO MISUSE. 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 DURING AN INITIAL TOTAL HIP ARTHROPLASTY PROCEDURE, THE INSERT WAS DIFFICULT TO IMPLANT IN THE SHELL. IT WAS REPORTED THAT AFTER REPEATED TESTS THE SURGEON USED ANOTHER INSERT TO COMPLETE THE PROCEDURE. THE EVENT CAUSED A DELAY OF 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225796 AVANTAGE UHMWPE INSERT PROSTHESIS, HIP LPH BIOMET FRANCE S.A.R.L. N/A 0001157118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention