BEUDAMED
    FDA Adverse Event Summary report: N

    LINEAR HIP

    MDR report key: 2991563 · Received March 6, 2013

    Report

    Report Number
    1644408-2013-00124
    Date Received
    March 6, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A PERI-PROSTHETIC FRACTURE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT ACTIVITY, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE 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 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 FIFTH COMPLAINT FOR THIS PART NUMBER: (B)(4) DUE TO TRAUMA, (B)(4) FOR INSTABILITY, AND (B)(4) REVISION SURGERY. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE REVISION SURGERY WAS MOST LIKELY DUE TO THE PERI-PROSTHETIC FRACTURE; THE CAUSE OF THE FRACTURE IS UNKNOWN BUT MAY BE ATTRIBUTED TO TRAUMA. 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 HAS A PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95321 LINEAR HIP STANDARD OFFSET STEM LPH ENCORE MEDICAL, L.P. 060C1014

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 411-00-035, LOT 90381075| 497-34-000, LOT 636C1039