BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2232347 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15648
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS RECEIVED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF FURTHER REVIEW IS REQUIRED. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED.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

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, DATE RECEIVED BY MANUFACTURER, PMA/510(K) #, MANUFACTURE DATE. THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2004, PT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER LEFT SIDE, AND ON OR ABOUT (B)(6) 2004, PT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER RIGHT SIDE. PT HAS LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES IN HER BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANTS. PT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER THIGHS AND GROIN. SHE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANTS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2004, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER LEFT SIDE, AND ON OR ABOUT (B)(6) 2004, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER RIGHT SIDE. PATIENT HAS LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES IN HER BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANTS. PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER THIGHS AND GROIN. SHE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANTS. UPDATE: (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS RECEIVED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF FURTHER REVIEW IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD NA 1229279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention