BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6IN AML SM STATURE 10.5MM

    MDR report key: 3488838 · Received November 26, 2013

    Report

    Report Number
    1818910-2013-34458
    Event Type
    Injury
    Date Received
    November 26, 2013
    Date of Event
    September 10, 2012
    Report Date
    May 8, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK061833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED LOT CODES 2881340, B4AJ31000, D74K71, DW7DV1000 OR 3025096 . 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    UDI: (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - PATIENT WAS REVISED TO ADDRESS PAIN. ALSO, THE SURGEON STATED THAT THERE WAS WHAT LOOKED LIKE THE BEGINNING STAGES OF CORROSION AT THE BASE OF THE HEAD, BUT NOTHING ON THE STEM. DOI (B)(6) 2010 - DOR (B)(6) 2012 (HIP). **UPDATE** LITIGATION PAPERS RECEIVED (B)(4) 2013. LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT. THE CUP, HOLE ELIMINATOR AND STEM ARE BEING REPORTED TO ADDRESS THESE ALLEGATIONS. THE COMPLAINT WAS UPDATED ON X.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, METAL ON METAL REACTION, CORROSION, AND WHITE FLUID WITHIN THE JOINT. LAB RESULTS FROM (B)(6) 2012 INDICATED METAL ION LEVELS WERE BELOW 7PPB.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615701 6IN AML SM STATURE 10.5MM STEM LPH DEPUY ORTHOPAEDICS INC US B4AJ31000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention