BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION HIP

    MDR report key: 3964312 · Received July 29, 2014

    Report

    Report Number
    1644408-2014-00488
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 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 TO REMOVE AND REPLACE THE ORIGINAL METAL-ON-METAL IMPLANTS THAT WERE IMPLANTED ON 05/22/2010. THE PRODUCT HAD AN IN-VIVO SERVICE LIFE OF 4.2 YEARS. NO INFORMATION WAS REPORTED WITH THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS REPORTED TO HAVE BEEN SENT TO A LAB PER INSTRUCTIONS 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 THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 54043017. A TOTAL OF 22 COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER BUT NONE ARE SIMILAR IN NATURE TO THIS EVENT IN THAT THIS WAS AN ELECTIVE SURGERY TO REMOVE PREVIOUSLY IMPLANTED COMPONENTS. NO REASON/ROOT CAUSE WAS SUPPLIED WITH THE PRODUCT COMPLAINT INDICATING THE REASON FOR THIS SURGERY OTHER THAN THE SURGEON'S DECISION TO REMOVE THE METAL-ON-METAL ORIGINAL IMPLANTS. THERE IS NO REPORTED INFORMATION THAT WOULD INDICATE A MATERIAL, DESIGN, OR MANUFACTURING ISSUE WITH THIS PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON WANTED TO REVISE THE PATIENT BECAUSE SHE HAD METAL-ON-METAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440948 FOUNDATION HIP METAL-ON-METAL LINER - NEUTRAL, MP7 KWA ENCORE MEDICAL, L.P. 54043017

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4), LOT 54048996| (B)(4), LOT 54041809| (B)(4), LOT A1000002