BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-POLAR ACETABULAR CUP

    MDR report key: 6316062 · Received February 9, 2017

    Report

    Report Number
    0001825034-2017-00559
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Report Date
    April 17, 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 · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, CATALOG#: 00877502802, LOT#: 2823164. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. AS RETURNED, THE LOCKING RING WAS IN THE CUP IN THE CORRECT ORIENTATION. ONE END OF THE LOCKING RING WAS BENT OUT OF THE GROOVE OF THE CUP. THE RING IS BOTH BENT AND TWISTED. THIS DEFORMATION WAS LIKELY OCCURRED UPON ATTEMPTED IMPLANTATION AND THE BENT RING STOPPED THE LINER IN MATING WITH THE SHELL. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. 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. 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

    Description of Event or Problem · 1

    DURING A PROCEDURE, THERE WAS DIFFICULTY SEATING THE ACETABULAR LINER IN THE CUP BECAUSE THE LOCKING RING WAS DEFORMED AND BENT. AN ALTERNATIVE LINER WAS USED TO COMLPETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103624 BI-POLAR ACETABULAR CUP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 611890

    Patients

    Seq Age Sex Outcome Treatment
    1