BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE SHELL

    MDR report key: 7937789 · Received October 5, 2018

    Report

    Report Number
    3006946279-2018-00357
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    December 2, 2017
    Report Date
    January 22, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  REFERENCE: STUCINSKAS, JUSTINAS, KALVAITIS, TOMAS, SMAILYS, ALFREDAS, ROBERTSSON, OTTO & TARASEVICIUSV SARUNAS (2017) COMPARISON OF DUAL MOBILITY CUP AND OTHER SURGICAL CONSTRUTS USED FOR THREE HUNDRED AND SIXTY TWO FIRST TIME HIP REVISIONS DUE TO RECURRENT DISLOCATIONS: FIVE YEAR RESULTS FROM LITHUANIAN ARTHROPLASTY REGISTER. INTERNATIONAL ORTHOPAEDICS 42:1015¿1020.HTTPS://DOI.ORG/10.1007/S00264-017-3702-0. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BEEN REVIEWED AS THE LOT NUMBER WAS NOT COMMUNICATED. ACCORDING TO THE AVAILABLE DATA, IT CANNOT BE DETERMINED IF A ZIMMER BIOMET PRODUCT WAS INVOLVED IN THIS EVENT AND THE EXACT ROOT CAUSE 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.

    Description of Event or Problem · 0

    JOURNAL ARTICLE REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION ON AVANTAGE CUP.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). REPORT SOURCE, LITERATURE - THIS EVENT HAS BEEN IDENTIFIED FROM THE JOURNAL ARTICLE OF JUSTINAS STUCINSKAS ET. AL (2017) "COMPARISON OF DUAL MOBILITY CUP AND OTHER SURGICAL CONSTRUTS USED FOR THREE HUNDRED AND SIXTY TWO FIRST TIME HIP REVISIONS DUE TO RECURRENT DISLOCATIONS: FIVE YEAR RESULTS FROM LITHUANIAN ARTHROPLASTY REGISTER", INTERNATIONAL ORTHOPAEDICS (SICOT) (2018) 42:1015-1020 THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED. THE DEVICE MANUFACTURING QUALITY RECORD COULD NOT BEEN REVIEWED AS THE ITEM AND LOT NUMBER OF THE PRODUCT WERE NOT COMMUNICATED. 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. ITEM AND LOT NUMBERS NOT COMMUNICATED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THROUGH THE JOURNAL ARTICLE "COMPARISON OF DUAL MOBILITY CUP AND OTHER SURGICAL CONSTRUTS USED FOR THREE HUNDRED AND SIXTY TWO FIRST TIME HIP REVISIONS DUE TO RECURRENT DISLOCATIONS: FIVE YEAR RESULTS FROM LITHUANIAN ARTHROPLASTY REGISTER" THAT 12 REVISIONS OCCURRED : 5 FOR DISLOCATIONS, 5 FOR INFECTION, 1 FOR PERIPROSTHETIC FRACTURE AND 1 FOR CUP LOOSENING. HOWEVER, WITH THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE IF THESE EVENTS INVOLVE AVANTAGE SHELLS (ZIMMER BIOMET) OR QUATRO VPS (GROUPE LÉPINE)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780303 AVANTAGE SHELL PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention