BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PE INLAY

    MDR report key: 3842701 · Received June 2, 2014

    Report

    Report Number
    1818910-2014-19868
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE RETURNED PARTS WERE TRANSFERRED TO CERAMTEC FOR INVESTIGATION. A REPORT WAS RECEIVED AND STATES: THE DENSITY OF THE BALL HEAD WAS ANALYZED AND FOUND TO BE COMPLYING WITH THE DELIVERY SPECIFICATION FOR BIOLOX FORTE COMPONENTS. THE MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS MEET THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. SECONDARY METAL TRANSFER AS A RESULT OF CONTACT WITH METAL PARTS AFTER THE FRACTURE EVENT CAN BE FOUND ON THE BALL HEAD. THE EXPECTED PRIMARY METAL TRANSFER CANNOT BE FOUND EQUALLY DISTRIBUTED ON THE BALL HEAD TAPER. THIS INDICATES A DISTURBANCE AT THE INTERFACE BETWEEN STEM AND BALL HEAD. THE PRIMARY FRACTURE SURFACES AND THE FRACTURE ORIGIN OF THE BALL HEAD CANNOT BE IDENTIFIED DUE TO SECONDARY DAMAGES. ABRASION ON THE INNER SPHERE OF THE PE INSERT INDICATES THAT THE FRACTURE OF THE BALL HEAD OCCURRED PRIOR TO THE EXPLANTATION. ON THE METAL STEM INTENSIVE DAMAGES CAN BE FOUND IN THE TAPER REGION WHICH INDICATES AN INTENSIVE CONTACT WITH FRAGMENTS OF THE BROKEN BALL HEAD OVER A LONG PERIOD PRIOR TO THE REVISION SURGERY. THE MENTIONED FALL OF THE PATIENT FROM THE LADDER IN COMBINATION WITH A DISTURBANCE AT THE INTERFACE BETWEEN THE STEM AND BALL HEAD LEAD TO AN INCREASE IN STRESSES, WHICH MAY HAVE CAUSED THE FRACTURE OF THE CERAMIC BALL HEAD. FURTHER INSPECTION OF THE PE INLAY WAS UNDERTAKEN AND PHOTOS WERE TAKEN (SEE ATTACHED). THIS CONFIRMED THAT THIS PRODUCT IS NOT A DEPUY PRODUCT AND THE ROOT CAUSE OF THIS COMPLAINT IS CONSIDERED AS OFF LABEL USE. THE USE OF NON DEPUY PRODUCTS IN CONJUNCTION WITH NON DEPUY PRODUCTS IS ADVISED AGAINST WITHIN THE IFU¿S PROVIDED. THE COMPLAINT SHALL BE CLOSED AS OFF LABEL USE; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Description of Event or Problem · 1

    SURGEON REPORTED FRACTURE OF CERAMIC HIP HEAD AFTER PATIENT FELL DOWN FROM A LADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320775 UNKNOWN PE INLAY HIP OTHER IMPLANT KXA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention