BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION HIP

    MDR report key: 3903099 · Received June 30, 2014

    Report

    Report Number
    1644408-2014-00408
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION WAS PAIN AND THE APPEARANCE OF A MASS IN THE LEFT GROIN AREA AFTER SIX YEARS EIGHT MONTHS IN VIVO; WHICH PROVED TO BE A CLOTTED HEMORRHAGE IN THE PSOAS BURSA. NO ACUTE INFLAMMATORY CELLS OR ORGANISMS WERE OBSERVED, AND THERE WAS NO EVIDENCE OF METALLOSIS. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS SENT TO AN OUTSIDE VENDOR FOR EVALUATION AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THERE ARE (B)(4) PRIOR COMPLAINTS AGAINST THE METAL-ON-METAL ACETABULAR LINER, PART NUMBER 499-34-008. IN (B)(4) OF THESE COMPLAINTS, A REVISION SURGERY WAS PERFORMED WHICH REVEALED THAT THE METAL INLAY DISSOCIATED FROM THE POLY LINER. IN (B)(4) OF THE COMPLAINTS, THE ENTIRE LINER DISSOCIATED FROM THE SHELL OR WOULD NOT LOCK INTO THE SHELL PROPERLY. IN (B)(4) OF THE COMPLAINTS, THE PATIENT WAS REPORTED TO HAVE HAD A REACTION TO THE METAL IN THE PROSTHESIS. THIS IS THE (B)(4) COMPLAINT FOR THE INCIDENT LOT NUMBER. THIS INVESTIGATION IS LIMITED IN SCOPE BECAUSE THE EXPLANTED PRODUCTS WERE NOT RETURNED TO DJO SURGICAL AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE REVISION SURGEON NOTED THAT THE METAL LINER COMPONENT WAS LOOSE IN THE POLY COMPONENT OF THE ACETABULAR LINER ASSEMBLY; IT IS NOT CLEAR WHETHER THE LOOSE COMPONENT MAY HAVE BEEN ASSOCIATED WITH THE HEMORRHAGE. SOME EVIDENCE OF DAMAGE WAS OBSERVED ON THE LOCKING MECHANISM OF THE POLY COMPONENT OF THE ACETABULAR LINER, RESULTING IN LOOSENESS OF THE METAL COMPONENT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT WAS THOUGHT TO HAVE HAD A METAL ALLERGIC REACTION, CAUSING A POSSIBLE TUMOR. THE SURGEON NOTED POSSIBLE FAILURE OF METAL INLAY LOCKING MECHANISM AND WEAR ON THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380410 FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL, MP8 KWA ENCORE MEDICAL, L.P. 53842580

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 497-34-000