BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X ARCOM XL H/W 54/36MM

    MDR report key: 2966038 · Received February 17, 2013

    Report

    Report Number
    3002806535-2013-00025
    Event Type
    Injury
    Date Received
    February 17, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 21, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. EVALUATION OF THE RETURNED COMPONENT SHOWED DAMAGE TO THREE OF THE SCALLOPS ON THE PROXIMAL SIDE AND MORE TO THE HIGH WALL ASPECT OF THE ACETABULAR LINER, HEAVY SCORE MARKS IN THE CIRCLIP GROOVE AND AN INDENT AT THE JUNCTURE OF THE CIRCLIP GROOVE AND OUTER SPHERICAL RADIUS, ALL OF WHICH WERE MOST LIKELY THE OUTCOME OF THE FITTING AND REMOVAL OF THE LINER DURING THE PROCEDURE. ALL MEASURED DIMENSIONS GENERALLY FELL WITHIN THE DRAWING TOLERANCE WITH THE EXCEPTION OF THE GROOVE DIAMETER WHICH IS SLIGHTLY UNDERSIZE, HOWEVER, THIS WOULD HAVE CAUSED NO OBSTRUCTION FOR THE CIRCLIP AS IT ONLY ALLOWS MORE CLEARANCE. THE COMPONENT WAS A SLACK FIT ON THE ACCEPTANCE GAUGE WITH THE SLIP GAUGE NOT PASSING UNDER THE FLANGE, BUT THIS GAUGE IS MANUFACTURED TO THE UPPER LIMITS. THE MANUFACTURING HISTORY RECORDS HAVE BEEN REVIEWED AND SHOWS THERE WERE NO RECORDED ERRORS WITH THE PARTS CHECKED AT THE TIME OF MANUFACTURE. THIS COULD MEAN THE LINER WAS MANUFACTURED AT OR BELOW THE BOTTOM LIMIT WHICH COULD HAVE GIVEN A LOOSE FIT WITH THE MATING ACETABULAR CUP, BUT WOULD NOT HAVE PREVENTED THE CIRCLIP FROM ENGAGING FULLY. WITHOUT FURTHER INFORMATION, A DEFINITELY CONCLUSION CANNOT BE FOUND TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BI-LATERAL HIP REPLACEMENT SURGERY ON (B)(6) 2012, SURGEON FELT THE LINER WAS TOO LOOSE AND THE LOCKING RING DIDN'T FUNCTION PROPERLY. ANOTHER LINER WAS USED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED, BUT A DELAY IN SURGERY OF 35 MINUTES WAS REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69910 RINGLOC-X ARCOM XL H/W 54/36MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2705263

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R