BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY METAL FEMORAL HEAD

    MDR report key: 2943921 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-11909
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    May 28, 2010
    Report Date
    January 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    MAUDE REPORT (B)(4) SUBMITTED BY AN UNKNOWN PARTY ON BEHALF OF A PATIENT STATES THAT PATIENT WAS REVISED TO ADDRESS PAIN, SWELLING WEAKNESS. METALOSIS WAS CONFIRMED DURING THE SURGERY. SEVERAL MONTHS LATER, THE PATIENT'S HIP DISLOCATED TWO TIMES AND WAS REVISED A SECOND TIME. THE REPORT DOES NOT INDICATE THE MANUFACTURER OF THE PRODUCT IMPLANTED AT EITHER OF THE REVISION SURGERIES. THE REPORT STATES THAT SHE CONTINUES TO SUFFER WITH LIMITED MOBILITY ISSUES AND INTERMITTENT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49379 UNKNOWN DEPUY METAL FEMORAL HEAD FEMORAL HEAD KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention