BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 56MM

    MDR report key: 2971642 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-01440
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 8, 2008
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K001534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. PHYSICIAN STATES IN REVISION SURGERY OPERATIVE NOTE THAT THE ACETABULAR COMPONENT WAS FOUND TO BE VERTICAL AND EXTREMELY ANTEVERTED. PHYSICIAN STATES THAT IT WAS FELT THAT THIS ABNORMAL CONDITION WAS CONTRIBUTING TO THE PATIENTS METALLOSIS WHICH WAS CAUSING THE INFLAMMATORY RESPONSE AND THE ELEVATED LABS. BASED ON THE PERFORMED INVESTIGATION, 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 INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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: 1/29/2013, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN, METALLOSIS, AND ANTEVERTED/VERTICAL CUP. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR AND METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76980 PINNACLE 300 ACET CUP 56MM TOTAL HIP REPLACEMENT LPH DEPUY ORTHOPAEDICS INC US Y2AFD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention