BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2113319 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08940
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. 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

    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

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 PAPERS ALLEGE: ON OR ABOUT (B)(6) 2008, PT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY PROCEDURE. A DEPUY PINNACLE DEVICE WITH AN ULTAMET LINER WAS IMPLANTED IN PLACE OF HER LEFT HIP. AFTER SURGERY, FRICTION AND WEAR BETWEEN METAL HEAD AND METAL LINER CAUSED LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PT'S BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. PT BEGAN EXPERIENCING SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN HER LEFT THIGH AND GROIN. PT ALSO EXPERIENCED PAIN AND DISCOMFORT WHENEVER MOVING TO AND FROM A SITTING POSITION AND WHEN STANDING. SHE ALSO CANNOT WALK W/O A CANE AND HAS A LIMP. PT HAS THE SENSATION THAT HER LEFT LEG IS WEAK AND THAT HER HIP WILL GIVE OUT ON HER. ADDITIONALLY, IT IS ALLEGED THAT PT WILL LIKELY UNDERGO REVISION SURGERY TO REPLACE THE PINNACLE DEVICE.

    Description of Event or Problem · 1

    UPDATED PART AND LOT NUMBERS OF THE IMPACTED PRODUCTS. ADDED STEM DUE TO PREVIOUSLY ALLEGED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS. ADDED PATIENT'S DOB, AGE AND LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS, INC. 1818910 NA 2743801

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention