BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 3180040 · Received June 13, 2013

    Report

    Report Number
    1644408-2013-00325
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LZO
    PMA / PMN Number
    K965002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY ON JUNE 3, 2013 WAS DUE TO A FRACTURE OF THE ZIRCONIA HEAD AFTER 13 YEARS AND 10 MONTHS IN-VIVO. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 1999. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SERIOUS RISK TO THE PATIENT. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT RETURNED 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 SHOWS THIS IS THE FIRST COMPLAINT FOR THIS PART NUMBER RELATED TO CERAMIC HEAD FRACTURE. THE ROOT CAUSE FOR THE FRACTURE CANNOT BE DETERMINED WITH CONFIDENCE SINCE THE COMPONENTS WERE NOT RETURNED. FACTORS THAT CAN CONTRIBUTE TO ZIRCONIA HEAD FAILURE INCLUDE: TRAUMA, AND EDGE LOADING, INSUFFICIENT JOINT TENSION LEADING TO INCREASED IMPACT LOADING. THERE IS NO EVIDENCE REVIEWED THAT SUGGESTS A DESIGN OR MANUFACTURING PROBLEM CONTRIBUTED TO THE FAILURE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD A FRACTURED CERAMIC HEAD OF THE TOTAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270345 FOUNDATION HIP HEAD, ZIRCONIA 28/+7 LZO ENCORE MEDICAL, L.P. 421031

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention