BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 RINGLOC BIPOLAR 28X52MM

    MDR report key: 11326030 · Received February 14, 2021

    Report

    Report Number
    0001825034-2021-00475
    Event Type
    Malfunction
    Date Received
    February 14, 2021
    Date of Event
    January 12, 2021
    Report Date
    July 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NOT CLEARED
    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. THE EVENT WAS CONFIRMED WITH PRODUCT RECEIVED. UPON VISUAL INSPECTION THE RETURNED LINER HAS CIRCULAR INDENTATIONS ON THE OUTSIDE RADIUS. THE LOCKING RING WAS RETURNED STILL INSTALLED IN THE SHELL WITH THE CHAMFER IN THE CORRECT POSITION AND THE LOCKING RING WAS BENT AND TWISTED. THE LOCKING RING WAS MEASURED FOR THE HEIGHT AND WIDTH AND WAS FOUND IN CONFORMANCE WITH THE PRINT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCTS: 00877502801 ¿ BIOLOX HEAD ¿ 3043648. REPORT SOURCE: (B)(6). THIS DEVICE IS NOT CLEARED BUT IS SAME OR SIMILAR TO K051569 PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE LINER WOULD NOT FIT INTO THE METAL CUP. A NEW LINER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. 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
    222873 E1 RINGLOC BIPOLAR 28X52MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 868450

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10