BEUDAMED
    FDA Adverse Event Injury Summary report: N

    54MM METAL ON METAL SHELL

    MDR report key: 3093978 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-16566
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM
    Product Code
    KWA
    PMA / PMN Number
    PK001523
    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

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING INVESTIGATION BY APPLIED RESEARCH AND BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: IT IS LIKELY IN THIS CASE THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE INVESTIGATION SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION. IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    IMPLANT REVISED DUE TO ON-GOING PAIN AND INCREASING ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197068 54MM METAL ON METAL SHELL ACETABULAR CUP KWA 1219655 DEPUY-RAYNHAM XXT08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention