BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE LINER

    MDR report key: 7941908 · Received October 8, 2018

    Report

    Report Number
    3006946279-2018-00360
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    February 5, 2018
    Report Date
    October 5, 2018
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). REPORT SOURCE, LITERATURE - THIS EVENT HAS BEEN IDENTIFIED FROM THE JOURNAL ARTICLE OF ANDERS BRÜGGEMANN, HANS MALLMIN & NILS P HAILER (2018) DO DUAL-MOBILITY CUPS CEMENTED INTO POROUS TANTALUM SHELLS REDUCE THE RISK OF DISLOCATION AFTER REVISION SURGERY? ACTA ORTHOPAEDICA, 89:2, 156-162, DOI: 10.1080/17453674.2018.1432927. PMA/510(K) NUMBER - THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET FRANCE AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K101336. 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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN THE JOURNAL ARTICLE OF ANDERS BRÜGGEMANN ET. AL (2018) "DO DUAL-MOBILITY CUPS CEMENTED INTO POROUS TANTALUM SHELLS REDUCE THE RISK OF DISLOCATION AFTER REVISION SURGERY? ACTA ORTHOPAEDICA, 89:2, 156-162", THAT ONE PATIENT IN THE DMC GROUP EXPERIENCED A DISLOCATION. THERE WAS NO MEDICAL INTERVENTION DUE TO THE PATIENT¿S POOR GENERAL HEALTH INHIBITING FURTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785743 AVANTAGE LINER PROSTHESIS, HIP LPH BIOMET FRANCE S.A.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability