BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE CUP

    MDR report key: 8285848 · Received January 29, 2019

    Report

    Report Number
    3006946279-2019-00074
    Event Type
    Injury
    Date Received
    January 29, 2019
    Report Date
    January 30, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDL
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PLEASE FIND ATTACHED THE JOURNAL ARTICLE RELATED TO (B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.   ATTACHMENT: [INTERNATIONAL ORTHOPAEDICS (2018) 42.1015¿1020.PDF]

    Description of Event or Problem · 0

    PLEASE REFER TO INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE : JOURNAL ARTICLE, FOREIGN - EVENT OCCURRED IN LITHUANIA. 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. 12 REVISIONS WERE MENTIONED IN THE ARTICLE: 5 FOR DISLOCATIONS, 5 FOR INFECTION, 1 FOR PERIPROSTHETIC FRACTURE, 1 FOR CUP LOOSENING. HOWEVER IT IS NOT POSSIBLE TO DETERMINE IF THESE EVENTS INVOLVE AVANTAGE CUP (ZIMMER BIOMET) OR QUATRO VPS (GROUPE LÉPINE). THIS COMPLAINT IS FOR THE CUP LOOSENING. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79909 AVANTAGE CUP PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) JDL BIOMET FRANCE S.A.R.L. N/A NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R