BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X ARCOM XL H/W 50/32MM

    MDR report key: 2988167 · Received March 4, 2013

    Report

    Report Number
    3002806535-2013-00034
    Event Type
    Injury
    Date Received
    March 4, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED, ITEMS REMAIN IMPLANTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP REPLACEMENT SURGERY ON AN UNKNOWN DATE, SURGEON HAD DIFFICULTY LOCKING THE LINER INTO THE SHELL. SURGEON ELECTED TO CONTINUE WITH THESE IMPLANTS. NO PATIENT INJURY WAS REPORTED, BUT A DELAY IN SURGERY OF GREATER THAN 30 MINUTES WAS REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92206 RINGLOC-X ARCOM XL H/W 50/32MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2841895

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization