BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 LINER RINGLOC-X 60MM

    MDR report key: 6332315 · Received February 15, 2017

    Report

    Report Number
    3002806535-2017-00070
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    December 6, 2016
    Report Date
    March 16, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS AND VIGILANCE ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: VISUAL CHECKS. THE RINGLOC-X E1 10DEG LINER INCLUDING THE PACKAGING HAS BEEN RETURNED FOR EVALUATION. THE FOLLOWING OBSERVATIONS HAVE BEEN FOUND: THE LINER HAS DAMAGE WITH DEEP INCISIONS ON THE EXTERNAL AND INTERNAL SPHERICAL SURFACES. THE LOCKING DEVICE IS DAMAGED AND SHOWS FRAYING OF THE POLY. THE SCALLOPS ON THE TOP / TAPERED EDGE ARE DAMAGED WITH PIECES OF POLY MISSING, DEFORMED AND BURRED. THE TOP FACE OF THE LINER HAS STRIKE INCISIONS. IT CANNOT BE DETERMINED WHERE THE DAMAGE TO THE LINER OCCURRED. EVIDENCE OF DAMAGE DURING THE MANUFACTURING PROCESS WOULD HAVE BEEN IDENTIFIED AT FINAL INSPECTION AND PACKAGING OF THE DEVICE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF THE COMPLAINTS DATA BASE FOR THE PAST 3 YEARS HAS FOUND NO SIMILAR REPORTED EVENTS FOR THIS ITEM LOT NUMBER COMBINATION. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510(K) NUMBER K023357.

    Description of Event or Problem · 1

    DURING A LEFT HIP ARTHROPLASTY, THE SURGEON HAD DIFFICULTY SEATING THE LINER. ANOTHER LINER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116109 E1 LINER RINGLOC-X 60MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3635876

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR