BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM ST,36+6L NK,11X16X150

    MDR report key: 2880241 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-29212
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    September 23, 2010
    Report Date
    November 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K954935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: 11/19/2012 - MEDICAL RECORDS RECEIVED . MEDICAL RECORDS INDICATE PATIENT WAS BI-LATERAL. PATIENT WAS REVISED ON THE LEFT HIP ON (B)(6) 2010 DUE TO SIGNIFICANT SUBSIDENCE. DOR: (B)(6) 2010 (LEFT HIP). MEDICAL RECORDS ARE LOCATED ON THE EXTERNAL HARD DRIVE. 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. NOT RETURNED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED SEVERE AND CONSTANT PAIN AND SUFFERING, SWELLING, BURSITIS, LACK OF MOBILITY, AND/OR METALLOSIS. **UPDATE** (B)(6) 2012-MEDICAL RECORDS RECEIVED . RECORDS ARE STORED ON DISC IF NEEDED. MEDICAL RECORDS INDICATE PATIENT WAS BI-LATERAL. PATIENT WAS REVISED ON THE LEFT HIP ON (B)(6) 2010 DUE TO SIGNIFICANT SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM STM ST,36+6L NK,11X16X150 STEM LPH DEPUY ORTHOPAEDICS INC US 1857501

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention