BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT44IDX64OD

    MDR report key: 2071482 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06673
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** 9/28/11 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND CORRECT DATE OF IMPLANT. FORM ALSO INDICATES THAT PATIENT WAS IMPLANTED WITH PINNACLE PRODUCTS, NOT ASR AS PREVIOUSLY MENTIONED. INVOICE WAS LOCATED, CONFIRMING THIS INFORMATION. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION. 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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, DATE RECEIVED BY MANUFACTURER, PMA/510(K) #, MANUFACTURE DATE. THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING ADDITIONAL INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND CORRECT DATE OF IMPLANT. FORM ALSO INDICATES THAT PATIENT WAS IMPLANTED WITH PINNACLE PRODUCTS, NOT ASR AS PREVIOUSLY MENTIONED. INVOICE WAS LOCATED, CONFIRMING THIS INFORMATION. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION. 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

    **UPDATE** (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND CORRECT DATE OF IMPLANT. FORM ALSO INDICATES THAT PATIENT WAS IMPLANTED WITH PINNACLE PRODUCTS, NOT ASR AS PREVIOUSLY MENTIONED. INVOICE WAS LOCATED, CONFIRMING THIS INFORMATION. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION. 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

    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

    PT IS SEEKING LEGAL ACTION.

    Description of Event or Problem · 1

    PATIENT IS SEEKING LEGAL ACTION. UPDATE: (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND CORRECT DATE OF IMPLANT. FORM ALSO INDICATES THAT PATIENT WAS IMPLANTED WITH PINNACLE PRODUCTS, NOT ASR AS PREVIOUSLY MENTIONED. INVOICE WAS LOCATED, CONFIRMING THIS INFORMATION. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT44IDX64OD NONE KWA DEPUY INTERNATIONAL, LTD. NA 2353156

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention