BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP LINER

    MDR report key: 2945068 · Received January 31, 2013

    Report

    Report Number
    1644408-2013-00047
    Event Type
    Other
    Date Received
    January 31, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY. THE PATIENT HAD A METAL REACTION. THE SURGEON REMOVED ALL OF THE IMPLANTS EXCEPT FOR THE STEM. THE IMPLANTS WERE CHANGED TO A BIOLOX DELTA HEAD AND THE REST OF THE IMPLANTS WERE REPLACED BY ZIMMER. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2006 AND THE PRODUCTS WERE IN VIVO FOR APPROXIMATELY 6.3 YEARS. BECAUSE NO COMPONENTS WERE RETURNED TO ENCORE MEDICAL (B)(4) SURGICAL, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. FACTORS THAT CAN LEAD TO METAL/METAL REACTION OR PAIN INCLUDE HYPERSENSITIVITY TO METAL, INCREASED METAL WEAR DUE TO HIGH PATIENT

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD AN ADVERSE REACTION.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD A METAL REACTION. THE SURGEON REMOVED ALL IMPLANTS EXCEPT FOR THE STEM AND REPLACED THE HEAD WITH A BIOLOX DELTA HEAD. THE REST OF THE IMPLANTS WERE REPLACED WITH ZIMMER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42198 FOUNDATION HIP LINER HIP LINER JDI ENCORE MEDICAL, L.P. 282442

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 010-55-030, LOT 53793612B| 430-01-054, LOT 53783795| 497-34-000, LOT 53808956| 411-00-000, LOT 53800098