BEUDAMED
    FDA Adverse Event Other Summary report: N

    R120 HIP

    MDR report key: 2931580 · Received January 22, 2013

    Report

    Report Number
    1644408-2013-00008
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K021822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, DJO SURGICAL WAS NOTIFIED BY AN AGENT OF A PRODUCT COMPLAINT THAT OCCURRED ON (B)(6) 2012 INVOLVING A MODULAR POROUS STEM. THE COMPLAINT PROVIDED THE FOLLOWING DESCRIPTION: THE MODULAR NECK DISSOCIATED FROM THE R120 STEM. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED. THE HEALTHCARE PROFESSIONAL INDICATED A SERIOUS RISK TO THE PATIENT. THERE WAS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, 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. THE DEVICE HISTORY RECORDS FOR THE MODULAR NECK, SLEEVE, AND FEMORAL HEAD WERE FOUND TO HAVE MET ALL CRITICAL DIMENSIONS AND SPECIFICATIONS SET FORTH BY THEIR DJO SURGICAL PRINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THREE PRIOR COMPLAINTS AGAINST THE MODULAR NECK: ONE DUE TO THE SURGEON NOT LIKING THE STABILITY AND DECIDED TO USE ANOTHER PART AND TWO FOR DISSOCIATION. THE ROOT CAUSE FOR THIS PRODUCT COMPLAINT IS THE MODULAR NECK DISSOCIATED FROM THE STEM. THE ROOT CAUSE FOR THE DISSOCIATION CANNOT BE DETERMINED WITH CONFIDENCE. FACTORS THAT CAN CONTRIBUTE TO THE DISSOCIATION INCLUDE: ASEPTIC LOOSENING, PATIENT ACTIVITY, TRAUMA, AND OTHER ISSUES. 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'S MODULAR NECK DISSOCIATED FROM THE R120 STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30019 R120 HIP MODULAR POROUS STEM JDI ENCORE MEDICAL, L.P. 53867004

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention (B)(4), LOT 54048991| (B)(4), LOT 53993334| (B)(4), LOT 53995541