BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+5

    MDR report key: 2860801 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-28369
    Event Type
    Injury
    Date Received
    December 6, 2012
    Report Date
    August 8, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    PATIENT IS RESIDENT OF (B)(6). UPDATE - (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, SIDE AND CORRECT IMPLANT DATE. MEDICAL RECORDS WERE ALSO RECEIVED, WHICH INDICATE THAT PATIENT WAS IMPLANTED WITH PINNACLE PRODUCTS, NOT ASR AS PREVIOUSLY MENTIONED. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION. DOI: (B)(6) 2007 (RIGHT SIDE). 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. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT DEVELOPED PAINFUL AND DANGEROUS COMPLICATIONS. UPDATE: (B)(6) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, SIDE AND CORRECT IMPLANT DATE. MEDICAL RECORDS WERE ALSO RECEIVED, WHICH INDICATE THAT PATIENT WAS IMPLANTED WITH PINNACLE PRODUCTS, NOT ASR AS PREVIOUSLY MENTIONED. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+5 FEMORAL HEAD LPH DEPUY ORTHOPAEDICS, INC. 1818910 2432674

    Patients

    Seq Age Sex Outcome Treatment
    1 Other