BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL COMPONENT

    MDR report key: 1192035 · Received October 6, 2008

    Report

    Report Number
    1818910-2008-04513
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSION ABOUT REPORTED DEVICE LOOSENING OR INFECTION. HOWEVER, MRSA INFECTION IS HIGHLY UNLIKELY TO BE PRODUCT RELATED. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS MRSA, FOUND LOOSE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY FEMORAL COMPONENT TOTAL KNEE REPLACEMENT HSA DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention