BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 RINGLOC BIPOLAR 28X50MM

    MDR report key: 7478956 · Received May 2, 2018

    Report

    Report Number
    0001825034-2018-03001
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Report Date
    November 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED; ALTHOUGH VISUAL ANALYSIS NOTED NO DAMAGE TO THE OUTSIDE RADIUS OF THE SHELL OR OF THE LINER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EVENT OCCURRED ON UNKNOWN DATE. CONCOMITANT PRODUCTS: ITEM # 6501158 DELTA CERAMIC FEMORAL HEAD 28/0MM T1 LOT#120650. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K051569

    Description of Event or Problem · 1

    IT WAS REPORTED ON AN UNKNOWN DATE, SURGEON FELT LINER/CUP DID NOT ARTICULATE SMOOTHLY. THIS SURGERY WAS FINISHED WITH BACKUP CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENT TO PATIENT REPORTED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323016 E1 RINGLOC BIPOLAR 28X50MM HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 512440

    Patients

    Seq Age Sex Outcome Treatment
    1