BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+1.5

    MDR report key: 2872426 · Received December 13, 2012

    Report

    Report Number
    1818910-2012-83698
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    April 1, 2009
    Report Date
    November 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    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

    UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, INFLAMMATION, DISCOMFORT, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE: (B)(6) 2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, INFLAMMATION, DISCOMFORT, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS IT WAS NOTED THAT THE PATIENT HAD A PROSTALAC HIP IMPLANTATION STATUS POST DEBRIDEMENT FOR INFECTION ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+1.5 TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS INC US 2373712

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention