BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER CUP CAGE

    MDR report key: 6096751 · Received November 11, 2016

    Report

    Report Number
    0001822565-2016-04192
    Event Type
    Injury
    Date Received
    November 11, 2016
    Report Date
    March 6, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/22325964. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. NO DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONALLY, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE PRODUCT NUMBER AND THE LOT NUMBER WERE NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE, THE DEVICE HISTORY RECORDS COULD NOT BE DETERMINED. INSUFFICIENT INFORMATION WAS PROVIDED TO PERFORM A COMPLAINT HISTORY SEARCH. THIS DEVICE IS USED FOR TREATMENT. INSUFFICIENT INFORMATION WAS PROVIDED TO PERFORM A COMPATIBILITY CHECK. SURGICAL NOTES WERE NOT PROVIDED. IT COULD NOT BE CONFIRMED IF THE DEVICES WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE ALSO UNKNOWN. STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICES CAUSED OR CONTRIBUTED TO PATIENT INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS EXPERIENCING AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746216 UNKNOWN ZIMMER CUP CAGE HIP PROSTHESIS KWZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other