BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE® TRANSCEND® CERAMIC FEMORAL HEAD

    MDR report key: 2873918 · Received December 14, 2012

    Report

    Report Number
    1043534-2012-01659
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 12, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01656, 01657, 01658. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    PER: KHO FC, ET AL., ORTHOPEDICS. 2012 NOV 1;35(11):E1581-5. "CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY: INCIDENCE AND RISK FACTORS OF BEARING SURFACE-RELATED NOISES IN 125 PATIENTS." CLINICAL STUDY OF PERFECTA STEM AND CUPS WITH BIOLOX FORTE CERAMIC-ON-CERAMIC BEARINGS (NO SPECIFIC CUP OR STEM SUB-BRAND SPECIFIED). ALLEGEDLY 1 REVISION AT 2 YEARS FOR ASEPTIC CUP LOOSENING (PT. HAD GASTRIC LYMPHOMA WITH ACET. BONE METASTASES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAGE® TRANSCEND® CERAMIC FEMORAL HEAD HIP COMPONENT, CODE:MRA MRA WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention