BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 5145335 · Received October 13, 2015

    Report

    Report Number
    2648920-2015-00365
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 16, 2015
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED VERSYS FEMORAL HEAD SHOWS DARK DEBRIS ON THE HEAD TAPER. IT HAS ALSO BEEN NOTED THAT THERE ARE SOME WEAR MARKS ON THE SURFACE OF THE HEAD. THE RETURNED VERSYS STEM HAS DARK DEBRIS ON THE STEM NECK TAPER. DIMENSIONS OF THE HEAD AND THE STEM WERE FOUND CONFORMING TO PRINT SPECIFICATIONS WHERE MEASURED. THE RETURNED LINER HAS A PLATINUM COLORED COATING. IT HAS ALSO BEEN NOTED THAT THERE IS PITTING ON THE ARTICULAR SURFACE INDICATIVE OF THIRD BODY WEAR AND ALSO THE LINER HAS GOUGES AND CUTS. DIMENSIONAL ANALYSIS CANNOT BE PERFORMED DUE TO THE CONDITION OF THE LINER. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. SCANNING ELECTRON MICROSCOPE IMAGES CONFIRM THE PRESENCE OF DARK DEBRIS ON THE HEAD TAPER AND SHOWS BASE METAL AND CU-DISPERSIVE X-RAY SPECTROSCOPY ANALYSIS OF THE DARK DEBRIS ON THE HEAD TAPER INDICATED THE ELEMENTS C, O, MG, SI, P, CA, CR, MN, CO, AND MO. THIS HAS BEEN A COMMON ELEMENT BREAKDOWN OF THE BLACK DEBRIS FOUND IN HIP FEMORAL CORROSION EVENTS. THESE DEVICES ARE USED FOR TREATMENT. 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. A DEFINITIVE ROOT CAUSE FOR THE CORROSION CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). OTHER DEVICES USED: THE FOLLOWING ARE MANUFACTURED BY ZIMMER INC. (B)(4): CATALOG #00630505036, TRILOGY LONGEVITY CROSSLINKED POLY LINER, LOT #62217089; CATALOG #65766201300, VERSYS FIBER METAL TAPER STEM, LOT #62547717; CATALOG #00620205020, TM ACETABULAR SHELL WITH MULTI HOLES, LOT #62573275. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO OSTEOLYSIS. DURING SURGERY, FOREIGN MATTER WAS FOUND IN THE FITTING OF THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677026 VERSYS FEMORAL HEAD JDI JDI ZIMMER, TURPEAUX INDUSTRIAL PARK 61896791

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention