BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HARRIS/GALANTE CUP

    MDR report key: 6067764 · Received October 31, 2016

    Report

    Report Number
    0001822565-2016-03995
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    October 10, 2016
    Report Date
    September 27, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001822565-2016-04355 AND 0001822565-2016-03994).

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT 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. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY WEAR. DURING THE SURGERY, THE LOCKING MECHANISM ON THE SHELL WAS DAMAGED WHILE THE NEW LINER WAS BEING INSERTED. SUBSEQUENTLY, THE CUP AND HEAD WERE ALSO REVISED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DAY FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718520 UNKNOWN ZIMMER HARRIS/GALANTE CUP HIP PROSTHESIS KWZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R