BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 52MM PINNACLE SHELL

    MDR report key: 3840534 · Received May 30, 2014

    Report

    Report Number
    1818910-2014-19782
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    EXAMINATION OF THE RETURNED DEVICES AND FINDS WEAR PATTERNS ON THE FEMORAL HEAD SUGGESTING THE LINER DISASSOCIATED AND CONTACTED THE ACETABULAR CUP. THE RETURNED LINER ALSO SHOWS SIGNS OF UNUSUAL WEAR, THREE OF THE ARDS HAVE BEEN FRACTURED, FURTHER INDICATING THE ECCENTRIC LOADING. VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS WEAR PATTERNS ON THE FEMORAL HEAD SUGGESTING THE LINER DISASSOCIATED FROM THE ACETABULAR COMPONENT, THEN ALLOWING THE FEMORAL HEAD TO CONTACT THE ACETABULAR CUP. HOWEVER, BECAUSE THE CUP WAS NOT RETURNED FOR EXAMINATION, MATCHING WEAR CANNOT BE CONFIRMED. THE RETURNED LINER ALSO SHOWS SIGNS OF UNUSUAL WEAR, FOUR OF THE ARDS HAVE BEEN FRACTURED, FURTHER INDICATING THE ECCENTRIC LOADING. ALSO NOTED WAS THE ABSENCE OF VISIBLE MARKS LEFT FROM A PROPER TAPER LOCK OF THE ACETABULAR LINER. THE WEAR NOTED ON THE ARTICULATING SURFACE OF THE ACETABULAR LINER FURTHER SUGGESTS THE FEMORAL HEAD WAS ECCENTRICALLY LOADED. THERE ARE MACHINING LINES YET VISIBLE WITHIN THE INNER RADIUS OF THE LINER WHICH WOULD NOT BE AS OBVIOUSLY PRESENT HAD THE FEMORAL HEAD BEEN MORE CENTRALLY LOADED. THE EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED AND THE POSSIBLY CONTRIBUTED TO THE SUBSEQUENT DISASSOCIATION OF THE LINER FROM THE CUP. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF DISASSOCIATION OF THE LINER FROM THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319349 UNKNOWN DEPUY 52MM PINNACLE SHELL HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention