BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 STANDARD +3MM LINER RINGLOC-X

    MDR report key: 6574881 · Received May 18, 2017

    Report

    Report Number
    3002806535-2017-00390
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    April 14, 2017
    Report Date
    March 2, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DATE - UNKNOWN DATE IN 2013. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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 K023357. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO BROKEN INSERT. THE PROSTHESIS WAS SQUEAKING AFTER A FALL AND X-RAYS SHOWED AN ECCENTRIC FEMORAL HEAD AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356107 E1 STANDARD +3MM LINER RINGLOC-X PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 2933225

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R UNKNOWN ACETABULAR SHELL| UNKNOWN FEMORAL HEAD| UNKNOWN FEMORAL STEM