BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 2961304 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-12360
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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 DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING.

    Description of Event or Problem · 1

    UPDATE MAY 18, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALSO ALLEGES NERVE IRRITATION AND LIMITED ROM. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, REVISION NOTES STATED THAT PATIENT WAS REVISED DUE TO PAIN AND ASPETIC LOOSENING OF LEFT HIP FEMORAL STEM. SCAR TISSUE WAS ALSO NOTED. SEROUS APPEARING FLUID WAS NOTED TO DRAIN FROM THE JOINT. NO GROSS EVIDENCE OF INFECTION WAS NOTED. NO GROSS METAL DEBRIS WAS NOTED WITHIN THE SOFT TISSUE. THIS COMPLAINT WAS UPDATED ON: MAY 24, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65046 UNKNOWN DEPUY FEMORAL HEAD TOTAL HIP REPLACEMENT KWY DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other