BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP

    MDR report key: 6646561 · Received June 16, 2017

    Report

    Report Number
    0001825034-2017-04094
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 24, 2017
    Report Date
    December 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    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). THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE COMPATIBILITY CHECK NOTE NO ISSUES. PHOTOGRAPHS IDENTIFIED THAT THE LINER WAS IN THE CUP AND THE INNER SIDE OF THE LINER EXHIBITS TWO HOLES WHICH LIKELY INDICATE THAT THE LINER WAS DRILLED TO DISENGAGE IT FROM THE CUP. THE LINER WAS LIKELY FRACTURED DURING SEPARATION. THE LINER AND CUP CANNOT BE FURTHER EVALUATED DUE TO THE QUALITY OF THE PHOTOS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 31-165326 229080 RINGLOC BIPOLAR REMVAL TL51-52. (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. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON COULD NOT DECOMPOSE THE LINER AND METAL SHELL USING A REMOVER INSTRUMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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
    429297 RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 606700

    Patients

    Seq Age Sex Outcome Treatment
    1