BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR PLASMA Z STEM

    MDR report key: 1821305 · Received August 27, 2010

    Report

    Report Number
    1821305
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 25, 2010
    Report Date
    August 27, 2010
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY MALE HAD HISTORY OF PRIMARY LEFT TOTAL HIP REPLACEMENT IN EARLY 2006 WITH A WRIGHT MEDICAL Z STEM. HE DID WELL POSTOPERATIVELY, RETURNING TO AN ACTIVE LIFE STYLE AND BOTH LEGS WERE OF EQUAL LENGTH. IN SUMMER OF 2010, AFTER WALKING ON HIS TREADMILL, HE FELT A SIGNIFICANT POP IN HIS LEFT HIP, FOLLOWED BY LEG PAIN AND DISABILITY. HE UNDERWENT REVISIONAL SURGERY SHORTLY THEREAFTER, REQUIRING A PROXIMAL FEMORAL OSTEOTOMY FOR REMOVAL OF THE STEM OF THE OLD IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR PLASMA Z STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI WRIGHT MEDICAL PHA00268 09527379

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R| S