BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 HI-WALL LINER RINGLOC-X

    MDR report key: 6609111 · Received June 2, 2017

    Report

    Report Number
    3002806535-2017-00469
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    March 19, 2015
    Report Date
    June 2, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K051569. THIS DEVICE AND EVENT WERE PREVIOUSLY REPORTED UNDER 0001825034-2016-05082. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION. SUBSEQUENTLY PATIENT EXPERIENCED SUPERFICIAL INFECTION AS WELL AS A URINARY TRACT INFECTION ON 8 DAYS POST-IMPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390268 E1 HI-WALL LINER RINGLOC-X PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3444987

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other