BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6IN AML LRG STATURE 12.0 MM

    MDR report key: 3895580 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-22006
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    February 8, 2012
    Report Date
    May 13, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK061833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE FEMORAL HEAD. PER PROCEDURE, THIS DEVICE IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. MEDICAL RECORDS AND X-RAYS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT (B)(4). REASON FOR ORIGINAL COMPLAINT- PATIENT WAS REVISED TO ADDRESS METAL WEAR AND OSTEOLYSIS. UPDATE REC'D ((B)(4) 2014) - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, DIFFICULTY AMBULATING AND METALLOSIS. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    UPDATE 5/13/15 AND 5/22/15 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT SUFFERED A GREATER TROCHANTER FRACTURE DURING SEATING OF THE 12.0 BROACH. THE FRACTURE WAS CABELED. THE UNKNOWN REAMER IS BEING CHANGED TO AN UNKNOWN BROACH. THE REVISION OPERATIVE NOTE INDICATED PAIN, INCREASED METAL IONS (CONFIRMED BY LABS) AND CORROSION. NO METALLOSIS, OSTEOLYSIS, OR PSEUDOTUMORS WERE FOUND. THE COMPLAINT WAS UPDATED ON:6/4/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370725 6IN AML LRG STATURE 12.0 MM HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US AV7JP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention