BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALFA HIP

    MDR report key: 3054964 · Received April 5, 2013

    Report

    Report Number
    1644408-2013-00197
    Event Type
    Other
    Date Received
    April 5, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K984227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2008, FOLLOWED BY A REVISION SURGERY ON (B)(6) 2012 TO REPLACE THE MODULAR FEMORAL NECK, UNIPOLAR OFFSET SLEEVE, AND 36MM COCR HEAD. THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2013, APPROXIMATELY 13 MONTHS AFTER. THERE IS NO INFORMATION IN THIS COMPLAINT REGARDING THE PATIENT'S ACTIVITY LEVEL, PAST MEDICAL HISTORY, AND WITH THE EXCEPTION OF THE PATIENT BEING OBESE; THERE IS NO PRE/POST OPERATIVE INFORMATION. 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 NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. THE ROOT CAUSE OF THIS FAILURE IS LIMITED IN SCOPE SINCE THE DEVICE WAS NOT MADE AVAILABLE FOR EXAMINATION. FACTORS THAT CAN CONTRIBUTE TO DISSOCIATION INCLUDE: TRAUMA, COMPONENT POSITIONING, PRIOR REVISION SURGERY REDUCING THE EFFECTIVENESS OF THE NECK CONNECTION, INADEQUATE IMPACTION FORCE, AND BLOOD/FLUID/DEBRIS ON THE TAPER SURFACES PRIOR TO IMPACTION. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE NECK SEPARATED FROM THE ALFA II STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139737 ALFA HIP MOD FEMORAL NECK 8 DEGREES 12/14 JDI ENCORE MEDICAL, L.P. 898B1003

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (B)(4), LOT 902B1025| (B)(4), LOT 638C1024