BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 10D 32IDX50OD

    MDR report key: 2920387 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-01375
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 4, 2012
    Report Date
    December 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K072963
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THE DOI: (B)(6) 2009 DOR: (B)(6) 2009 FOR RECURRENT DISLOCATION; DOR: (B)(6) 2012 FOR PAIN AND LEG LENGTH DISCREPANCY. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. (RIGHT HIP). 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 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED PAIN, SWELLING, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, PSEUDOTUMOURS, BURSITIS, AND BONE EROSION. UPDATE: (B)(6) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THE DOI: (B)(6) 2009 DOR: (B)(6) 2009, FOR RECURRENT DISLOCATION; DOR: (B)(6) 2012 FOR PAIN AND LEG LENGTH DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25343 ALTRX +4 10D 32IDX50OD HIP LINER LPH DEPUY ORTHOPAEDICS INC US DB7HV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention