BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE METAL LINER

    MDR report key: 2861367 · Received December 7, 2012

    Report

    Report Number
    1818910-2012-25557
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 19, 2013
    Manufacturer
    FACILITY NAME: DEPUY INTL., LTD. ? REG. # 8010379
    Product Code
    KWA
    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

    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. REF. (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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE 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 DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    **UPDATE: LITIGATION PAPERS RECEIVED (B)(4) 2013. AMENDED LITIGATION PAPERS RECEIVED. ORIGINAL LITIGATION INDICATED THAT THE PATIENT WAS IMPLANTED WITH ASR; HOWEVER, AMENDED LITIGATION ALLEGES THAT THE PATIENT WAS IMPLANTED WITH PINNACLE. LITIGATION ADDITIONALLY ALLEGES POPPING AND SNAPPING. DATE OF IMPLANT HAS ALSO BEEN PROVIDED. THE PRODUCTS HAVE BEEN UPDATED AND FOLLOW-UPS CREATED. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED THAT ALLEGE THE PATIENT SUFFERED FROM PAIN, DISCOMFORT, THE FORMATION OF METALLOSIS AND PSEUDOTUMORS WHICH HAVE DAMAGED BONE AND TISSUE SURROUNDING THE IMPLANT, STIFFNESS, INFLAMMATION, CHROMIUM AND COBALT METAL TOXICITY AND LACK OF MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PINNACLE METAL LINER METAL LINER KWA FACILITY NAME: DEPUY INTL., LTD. ? REG. # 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other