BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN E-POLY HI WALL RINGLOC ACETABULAR LINER

    MDR report key: 6323893 · Received February 10, 2017

    Report

    Report Number
    0001825034-2017-00430
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    June 9, 2016
    Report Date
    April 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: SELEX/MAGNUM FEMORAL HEAD CATALOG#: S031140 LOT#: 744980, ECHO BI-METRIC FEMORAL STEM CATALOG#: 192012 LOT#: 190370, MALLORY HEAD ACETABULAR CUP CATALOG#: 13-104154 LOT#:101710, LOW PROFILE SCREW CATALOG#: 103532 LOT#'S: 618940 & 618810. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT¿S RIGHT HIP WAS REVISED APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106919 UNKNOWN E-POLY HI WALL RINGLOC ACETABULAR LINER HIP PROSTHESIS MAY BIOMET ORTHOPEDICS N/A 546620

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R