BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PLATES

    MDR report key: 2688904 · Received August 9, 2012

    Report

    Report Number
    0001825034-2012-01247
    Event Type
    Injury
    Date Received
    August 9, 2012
    Date of Event
    August 1, 2012
    Report Date
    July 16, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01247 / 01249). THIS MEDWATCH CORRESPONDS WITH THE EVENT REPORTED IN THE ATTACHED MAUDE REPORT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND REVISION DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01247-1 / 01249-1).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND CORRECTED DATA, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01247-2 / 01249-2).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL ANKLE PROCEDURE ON (B)(6) 1994. SUBSEQUENTLY, PATIENT ALLEGES ELEVATED CHROMIUM LEVELS, PAIN, SWELLING AND POPPING DUE TO LOOSENING THAT BEGAN APPROXIMATELY TWO YEARS AGO. PATIENT IS CURRENTLY CONSULTING WITH DOCTOR WHO IS ADVISING A REVISION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL ANKLE PROCEDURE ON (B)(6) 1994. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGED ELEVATED CHROMIUM LEVELS, PAIN, SWELLING AND POPPING DUE TO LOOSENING THAT BEGAN APPROXIMATELY TWO YEARS AGO. IT WAS STATED IN MEDICAL RECORDS REVISION DUE TO PAIN AND LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL ANKLE PROCEDURE ON (B)(6) 1994. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2012 DUE TO PATIENT ALLEGED ELEVATED CHROMIUM LEVELS, PAIN, BENT METAL PLATE, FRACTURED SCREWS INTO BONE AND CAUSING INTERNAL BLEEDING, SWELLING AND POPPING, PINCHING AND SKIN PROTRUDING DUE TO LOOSENING THAT BEGAN APPROXIMATELY TWO YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PLATES PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R