BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE CUP

    MDR report key: 8247738 · Received January 15, 2019

    Report

    Report Number
    3006946279-2019-00040
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    January 19, 2015
    Report Date
    August 29, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTION HAS BEEN UPDATED : B3, B5, D1, D2, D3, D6, D7, D11, E1, G1-2, G4, H2, H3, H6, H10. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE SURGICAL REPORT HAS BEEN REVIEWED. THE REVIEWED OF SURGICAL REPORT SHOWS THAT DURING THE REVISION OF THE CUP, THE LOOSENING WAS CONFIRMED BY THE SURGEON. THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BEEN REVIEWED AS THE ITEM AND LOT NUMBER OF THE PRODUCT WERE NOT COMMUNICATED. 6 COMPLAINTS (INCLUDING THE CURRENT COMPLAINT) ON THE ISSUE HAS BEEN RECORDED FOR AVANTAGE CUP WITHIN ONE YEAR. AS BIOMET FRANCE DID NOT RECEIVE ANY INFORMATION ABOUT THE INVOLVED BATCH NUMBER AND AS THE PRODUCT HAS NOT BEEN RETURNED, BIOMET FRANCE WAS NOT ABLE TO PERFORM ANY BATCH AND MANUFACTURING DOCUMENTATION REVIEW AND PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT 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. H3 OTHER TEXT : ITEM AND LOT NOT COMMUNICATED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP PROSTHESIS IMPLANTED IN 2003 DUE TO COXARTHROSE. THE SURGERY CONSISTED ON THE IMPLANTATION OF AVANTAGE CUP, INSERT AND AURA STEM. ON (B)(6) 2014, THE SURGEON DIAGNOSED AN ASEPTIC LOOSENING A PRIORI UNIPOLAR RIGHT TOTAL HIP PROSTHESIS. ON (B)(6) 2015, A REVISION SURGERY HAS BEEN PERFORMED (THE HEAD AND CUP WERE REMOVED, POLYETHYLENE INSERT WEAR AND MAJOR METALLOSIS WERE NOTICED). THE PRODUCTS WERE REPLACED BY PRODUCTS FROM AMPLITUDE. ON (B)(6) 2018 AFTER A FIRST REVISION SURGERY OCCURRED ON (B)(6) 2015, THE PATIENT CAME BACK DUE TO A BRUTAL FUNCTIONAL IMPOTENCE BY WALKING. REVISION SURGERY WAS PERFORMED TO REMOVE THE FRACTURED STEM AND THE OTHER AMPLITUDE PRODUCTS IMPLANTED ON (B)(6) 2015 (THIS REVISION DUE TO IMPLANT FRACTURE HAS BEEN REPORTED IN (B)(4)). NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO BREAKAGE OF THE MODULAR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42683 AVANTAGE CUP PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L. N/A NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R INSERT AVANTAGE,AURA STEM.