BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SHLL WITH HOLES

    MDR report key: 4908203 · Received July 9, 2015

    Report

    Report Number
    2648920-2015-00242
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    June 8, 2015
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR REVIEW AS IT REMAINS IMPLANTED, THEREFORE ITS CONDITION CANNOT BE DESCRIBED. MANUFACTURING DOCUMENTATION WAS REVIEWED AND FOUND CONFORMING TO SPECIFICATIONS AT THE TIME OF MANUFACTURE. THESE DEVICES WERE USED IN THE TREATMENT OF A MEDICAL CONDITION. THE DEVICE WAS IMPLANTED WITH NON-COMPATIBLE, COMPETITOR PRODUCT. THIS IS CONSIDERED AN OFF-LABEL USE OF THE DEVICE, WHICH IS INDICATED IN THE PACKAGING INSERT, AS ZIMMER HAS NOT TESTED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FROM THIS MANUFACTURING LOT. WITH THE INFORMATION PROVIDED, THE USED FAILED TO FOLLOW INSTRUCTIONS AND IMPLANTED THE ZIMMER SHELL WITH A NON-INDICATED COMBINATION OF PRODUCT. THIS MAY BE CONTRIBUTING TO THE FAILURE OF THE PATIENT'S HIP PROSTHESIS, HOWEVER THIS CANNOT BE STATED WITH CERTAINTY.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT HAS EXPERIENCED AN INJURY AFTER BEING IMPLANTED WITH A ZIMMER TRILOGY SHELL WITH HOLES, A JRI FEMORAL HEAD, AND JRI FEMORAL STEM. THESE PRODUCTS ARE NOT AN APPROVED COMPATIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446251 TRILOGY ACETABULAR SHLL WITH HOLES LPH ZIMMER 60109193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other