BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 5486384 · Received March 8, 2016

    Report

    Report Number
    2648920-2016-00075
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    January 29, 2016
    Report Date
    February 9, 2016
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #65771101200, ZIMMER M/L TAPER FEMORAL STEM PRESS-FIT PLASMA SPRAYED, LOT #62335624- REMAINS IMPLANTED MANUFACTURED BY ZIMMER INC. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RECEIVED, BUT NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    THE FEMORAL HEAD WAS RETURNED FOR REVIEW. INSPECTION OF THE RETURNED HEAD CONFIRMS SOME DARK DEBRIS ON THE FEMORAL HEAD TAPER. OPTICAL MACROGRAPHS AND SEM IMAGES CONFIRM THE PRESENCE OF DARK DEBRIS ON THE HEAD. THE EDM ANALYSIS OF THE DARK DEBRIS ON THE HEAD INDICATED ELEMENTS C, O, P, CA, TI, CR, CO, AND MO. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE FEMORAL HEAD WAS MANUFACTURED ON MAY 6, 2013. FEMORAL STEM 12/14 NECK TAPER WAS NOT RETURNED AND REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THESE DEVICES ARE USED FOR TREATMENT. PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATION FOR BOTH HEAD AND THE STEM. REVIEW OF THE COMPATIBILITY OF THE DEVICES CONFIRMED THAT THESE ARE AN APPROVED 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¿S ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142305 VERSYS FEMORAL HEAD JDI JDI ZIMMER, TURPEAUX INDUSTRIAL PARK 62354616

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention