BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA V-40 CERAMIC HEAD 32/-4

    MDR report key: 3781479 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01554
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A DELTA CERAMIC HEAD WAS REPORTED. THE EVENT AS CONFIRMED. A MATERIAL ANALYSIS INDICATED - WEAR SCARS ON THE RETURNED CERAMIC HEAD AND ALUMINA INSERT WERE OBSERVED AND WERE CONSISTENT WITH IN-VIVO USE. TITANIUM MATERIAL TRANSFER WAS PRESENT ON THE CERAMIC HEAD AND ALUMINA INSERT ARTICULATING SURFACES, LIKELY FROM OTHER HIP IMPLANT COMPONENTS. LIKELY FEMORAL STEM IMPINGEMENT DAMAGES WERE OBSERVED ON THE INSERT SLEEVE. NO MATERIALS OR MANUFACTURING DEFECTS WERE PRESENT IN THE RETURNED DEVICE. DEVICE HISTORY REVIEW INDICATED THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE DAMAGE WAS CAUSED BY IN-VIVO USE. THERE WERE NO MATERIAL OR MANUFACTURING DEFECTS NOTED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED ACETABULAR REVISION SURGERY DUE TO BONE GRAFT FAILURE. THE SURGEON RETRIEVED THE IMPLANTS AND NOTICED "MARKS" ON THE HEAD OF THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED ACETABULAR REVISION SURGERY DUE TO BONE GRAFT FAILURE. THE SURGEON RETRIVED THE IMPLANTS AND NOTICED "MARKS" ON THE HEAD OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260915 DELTA V-40 CERAMIC HEAD 32/-4 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 10@523722

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R