BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC-X E1 H/W 58/40MM 25

    MDR report key: 5773407 · Received July 6, 2016

    Report

    Report Number
    3002806535-2016-00530
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    May 25, 2016
    Report Date
    June 6, 2016
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. PMA/510(K) - 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 IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023357. REQUESTED BUT NOT YET RETURNED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY PRODUCT EVALUATION RESULTS. REVIEW OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE. DIMENSIONAL ANALYSIS INDICATES THE PRODUCT IS CONFORMING TO PRINT SPECIFICATIONS. VISUAL INSPECTION REVEALS MARKS ON THE INNER SURFACE OF THE LINER, AS WELL AS MARKS ON THE EXTERNAL SURFACE WHERE THE LINER HAS COME IN CONTACT WITH AN ACETABULAR SCREW OR THE INTERNAL ACETABULAR SHELL HOLES. THE MOST LIKELY ROOT CAUSE OF THE EVENT IS INCORRECTLY SEATED ACETABULAR SCREWS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ACETABULAR LINER WOULD NOT SEAT WITHIN THE CUSTOM IMPLANT. ANOTHER ACETABULAR LINER WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427616 RINGLOC-X E1 H/W 58/40MM 25 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 2932746

    Patients

    Seq Age Sex Outcome Treatment
    1