BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTAGE DUAL MOBILITY CUP DMC

    MDR report key: 8169390 · Received December 17, 2018

    Report

    Report Number
    3006946279-2018-00394
    Event Type
    Death
    Date Received
    December 17, 2018
    Date of Event
    February 5, 2018
    Report Date
    January 22, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDL
    PMA / PMN Number
    N/A
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORT SOURCE, LITERATURE, 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, HTTPS://DOI.ORG/10.1080/17453674.2018.1432927. THE REFERENCE AND BATCH NUMBERS WERE NOT COMMUNICATED AND THE PRODUCT WAS NOT RETURNED. 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, THE EXACT ROOT CAUSE CANNOT 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.

    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

    PLEASE REFER TO REPORT 3006946279-2018-00394.

    Description of Event or Problem · 1

    JOURNAL ARTICLE REPORTED THAT 5 PATIENTS DIED. THEY WERE IMPLANTED WITH AVANTAGE DUAL MOBILITY CUP DMC AND THE CAUSES OF DEATHS WERE NOT LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011369 AVANTAGE DUAL MOBILITY CUP DMC 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 Death