BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER STEM

    MDR report key: 5149738 · Received October 14, 2015

    Report

    Report Number
    1822565-2015-02139
    Event Type
    Injury
    Date Received
    October 14, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE PART AND LOT NUMBERS OF THE DEVICES ARE UNKNOWN; THEREFORE THE MANUFACTURING RECORDS, COMPLAINT HISTORY COULD NOT BE REVIEWED. THE REPORTED DEVICES ARE USED FOR TREATMENT. IT COULD NOT BE CONFIRMED IF THE DEVICES WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. SURGICAL NOTES WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS SUCH AS RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS11999-013-3167-4/FULLTEXT.HTML. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT IN 4 PATIENTS, THE STEMS WERE DETERMINED TO BE LOOSE ON PLAIN RADIOGRAPHS AND UNDERWENT REPEAT FEMORAL REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679943 UNKNOWN ZIMMER STEM HIP PROSTHESIS KWZ ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention