BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 RINGLOC BIPOLAR 28X47MM

    MDR report key: 6539803 · Received May 3, 2017

    Report

    Report Number
    0001825034-2017-02985
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Report Date
    August 2, 2018
    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 · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EXAMINATION OF THE RETURNED LINER RING CONFIRMS THE REPORTED MATERIAL DEFORMATION IDENTIFIED PRIOR TO USE. THE MATING SHELL/LINER WERE NOT RETURNED FOR EVALUATION AS THEY WERE IMPLANTED WITH ANOTHER RING FROM ANOTHER DEVICE, THEREFORE THE DEVICE-DEVICE INCOMPATIBILITY COULD NOT BE EVALUATED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). (B)(4). CONCOMITANT MEDICAL PRODUCTS - UNKNOWN LINER, UNKNOWN STEM, UNKNOWN HEAD EVENT OCCURRED IN (B)(6) . ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). 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 THAT DURING AN INITIAL HIP SURGERY, THE LINER DID NOT INSERT INTO THE SHELL. PROCEDURE WAS FINISHED WITH ANOTHER LOCKING RING. THERE WAS NO DELAY OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323902 E1 RINGLOC BIPOLAR 28X47MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 880920

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE