BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 2972967 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-04022
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    April 3, 2010
    Report Date
    January 30, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWC
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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 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).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AND DISCOMFORT, WHICH NEGATIVELY AFFECTED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING. BLOOD TESTS HAVE REVEALED CONSISTENTLY ELEVATED LEVELS OF CHROMIUM AND COBALT. UPDATE: (B)(4) 2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATE THAT A BROKEN SCREW WAS FOUND AT THE REVISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76668 PINN CAN BONE SCREW 6.5MMX25MM SCREW HWC DEPUY ORTHOPAEDICS INC US AP2CF4000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention