BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLICA LG STAT LNG LT 16.5MM

    MDR report key: 3042387 · Received April 9, 2013

    Report

    Report Number
    1818910-2013-15078
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK934334
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 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

    (B)(4). UPDATE: 8/16/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATE THAT THE PATIENT WAS REVISED ON THE LEFT HIP BECAUSE OF PAIN, ELEVATED ION LEVELS, AND CORROSION. THERE WAS A CRACK AT THE PRIMARY SURGERY WHICH WAS LEFT ALONE AND DID NOT FACTOR INTO THE REASONS FOR REVISION. THE RIGHT HIP HAS NOT BEEN REVISED BUT THE PATIENT ALSO RECEIVED A SMALL CRACK AT THE PRIMARY BUT DID NOT CAUSE A SERIOUS INJURY. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. BILATERAL- DOI: (B)(6) 2004- DOR: (B)(6) 2012 (LEFT HIP). DOI: (B)(6) 2004- DOR: NONE REPORTED (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE UX9M21003. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 1091329, 1122819, 1125687 AND 1122211 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM DISCOMFORT, PAIN, A LIMP, AND ELEVATED LEVELS OF COBALT CHROMIUM. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM LOOSENING OF THE LEFT SIDE.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144970 REPLICA LG STAT LNG LT 16.5MM FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US UX9M21003

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention