BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 3679104 · Received February 14, 2014

    Report

    Report Number
    1644408-2014-00058
    Event Type
    Other
    Date Received
    February 14, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION SURGERY WAS METALLOSIS. NO INFORMATION ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, MEDICAL CONTRAINDICATIONS, ALLERGIES, 3RD BODY WEAR OR OTHER FACTORS THAT COULD HAVE CONTRIBUTED TO REVISION WAS PROVIDED WITH THIS COMPLAINT. NO X-RAYS OF THE COMPONENTS IN-VIVO WERE PROVIDED FOR REVIEW. 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 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 WERE (B)(4) TOTAL COMPLAINTS AGAINST THE INCIDENT M-M LINER PART FAMILY. (B)(4) OF THE PRIOR COMPLAINTS WERE ON THE INCIDENT PART NUMBER (B)(4). OF THESE (B)(4) COMPLAINTS, (B)(4) COMPLAINTS WERE FOR INFECTION, (B)(4) WERE FOR DISLOCATION, (B)(4) WERE FOR WEAR, AND (B)(4) WAS FOR PAIN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SEVERAL FACTORS THAT CAN CONTRIBUTE TO THIS EVENT INCLUDE HYPERSENSITIVITY TO METAL, INCREASED METAL WEAR DUE TO HIGH PATIENT ACTIVITY LEVEL, MALPOSITION OF COMPONENTS, TRAUMA, OR EXCESSIVE RANGE-OF-MOTION. THERE IS NO EVIDENCE THAT A MATERIAL, DESIGN, OR DIMENSIONAL PROBLEM CONTRIBUTED TO REVISION SURGERY.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD METALLOSIS; THE SURGEON LEFT THE PT HAD A HIGH METAL BLOOD COUNT. HE REMOVED THE METAL-METAL LINER AND HEAD AND REPLACED THEM WITH A HXL/FMP LINER AND COCR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98521 FOUNDATION HIP METAL-ON-MEGAL LINER - NAUTRAL, MP5 KWA ENCORE MEDICAL, L.P. 845601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention