BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALFA HIP

    MDR report key: 2792477 · Received October 5, 2012

    Report

    Report Number
    1644408-2012-00520
    Event Type
    Other
    Date Received
    October 5, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K032729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 AN AGENT REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO MODULAR NECK DISSOCIATION. THE ORIGINAL SURGERY WAS PERFORMED ON OR ABOUT (B)(6) 2007, MEANING THE COMPONENTS HAD BEEN IN-VIVO APPROXIMATELY FIVE YEARS AND TWO MONTHS AT THE TIME OF THE DISSOCIATION. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED TWO MODULAR NECK PARTS WERE SCRAPPED DURING THE LATHE OPERATION DUE TO NON-CONFORMING DIMENSIONS. THIS OPERATION CREATES THE NON-CERASIVE TAPER AND THE SCALLOPS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE INCIDENT MODULAR NECK LOT. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS WERE MET FOR THE EIGHT RELEASED PARTS. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THERE IS TWO PRIOR COMPLAINTS AGAINST THE MODULAR NECK FOR DISSOCIATION AND STABILITY. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE REVISION SURGERY IS DISSOCIATION. BECAUSE NO COMPONENTS WERE RETURNED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. FACTORS THAT CAN CONTRIBUTE TO DISSOCIATION INCLUDE: TRAUMA, COMPONENT POSITIONING, EXCESSIVE PHYSICAL ACTIVITY, INADEQUATE IMPACTION FORCE, AND BLOOD/FLUID/DEBRIS ON THE TAPER SURFACES PRIOR TO IMPACTION. 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 HAD MODULAR NECK DISSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALFA HIP MOD FEM NECK 12 12/14 CERASIVE TAPER LPH ENCORE MEDICAL, L.P. 53811708

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 497-38-000: LOT 53797691| 499-38-010: LOT 255352| 411-00-700: LOT 53784063