BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACE SYSTEM

    MDR report key: 2003945 · Received February 23, 2011

    Report

    Report Number
    MW5019563
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ZIMMER RANDALL ASSOC
    Product Code
    KWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A TOTAL HIP ARTHROPLASTY DONE IN (B)(6) 2010, AND RETURNED TO THE PHYSICIAN'S OFFICE FOR HER 6 MONTH CHECK-UP. WHEN AN X-RAY WAS DONE, IT WAS NOTED THAT THE POLYETHYLENE LINER OF HER RIGHT TOTAL HIP ARTHROPLASTY HAD SLIPPED LOOSE. SHE RETURNED TO SURGERY ON (B)(6) 2011, AND IT WAS FOUND THAT THE POLYETHYLENE HAD SPLIT IN HALF AND MODERATE METALLOSIS OF THE CAPSULE HAD OCCURRED. SHE REQUIRED REVISION OF THE POLYETHYLENE LINER, WITH REPLACEMENT OF THE NECK AND HEAD, DEBRIDEMENT OF CAPSULE/METALLOSIS. THE COMPANY REP WAS PRESENT AT THE TIME OF SURGERY AND TOOK THE FAILED LINER BACK TO THE COMPANY. THE CAPSULE WAS SENT TO CHECK FOR WBC AND NO WBCS WERE NOTED. PRIOR TO SURGERY, THE PT HAD DEVELOPED PAIN IN HER HIP AND WAS WALKING WITH A LIMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACE SYSTEM ACETABULAR LINER KWZ ZIMMER RANDALL ASSOC 6320-48-32 61456669

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| S