BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP

    MDR report key: 6642746 · Received June 15, 2017

    Report

    Report Number
    0001825034-2017-03866
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Report Date
    June 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN LINER, UNKNOWN HEAD, UNKNOWN STEM. (B)(6). 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510K NUMBER K051569. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RING OF A METAL SHELL WAS DEFORMED. THE SURGERY WAS COMPLETED WITH A SECOND DEVICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425859 RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 639470

    Patients

    Seq Age Sex Outcome Treatment
    1