BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 32IDX60OD

    MDR report key: 2251823 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18204
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    October 6, 2010
    Report Date
    August 19, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K001534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE KNOWN PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. PRODUCT/LOT INFORMATION WAS NOT PROVIDED FOR THE FEMORAL HEAD ASSOCIATED WITH THIS REPORT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    **UPDATE** 11/20/2012 - MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. DOI: (B)(6) 2007 - DOR:(B)(6) 2010 (LINER/HEAD EXCHANGED, (B)(6) 2010 (CUP/LINER REMOVED DUE TO DISASSOCIATION, THE CUP WAS PREVIOUSLY REPORTED ON (B)(4)) THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. A SEARCH OF THE COMPLAINT DATABASE AND / OR DHR REVIEW WAS NOT POSSIBLE FOR THE UNKNOWN FEMORAL HEAD 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 IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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). ADDED: EXPIRATION DATE.

    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

    LITIGATION PAPERS ALLEGE: ON (B)(6), 2007, PATIENT WAS IMPLANTED WITH A PINNACLE CUP, LINER, AND HEAD. ON (B)(6), 2010, PATIENT WAS REVISED DUE TO DISASSOCIATION (REPORTED IN A SEPARATE COMPLAINT) AND IMPLANTED WITH A NEW DEPUY PINNACLE LINER. PATIENT WAS REVISED AGAIN ON (B)(6), 2010, DUE TO DISASSOCIATION. THE CUP, HEAD, AND SECOND LINER, WERE ALL REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR NEUT 32IDX60OD ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US CS3FJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention