BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2933391 · Received January 29, 2013

    Report

    Report Number
    1818910-2013-01552
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    August 9, 2016
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    EPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. WWCAPA (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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT; THE FORMATION OF METALLOSIS AND PSEUDOTUMORS WHICH HAVE DAMAGED BONE AND TISSUE SURROUNDING THE IMPLANT; STIFFNESS; INFLAMMATION; CHROMIUM AND COBALT METAL TOXICITY; LACK OF MOBILITY; AND OTHER COMPLICATIONS. PPD RECEIVED (B)(4) 2012. UPDATE: 2/4/2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED CORRECT IMPLANT DATE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE ¿ 08/09/2016 PFS RECEIVED. AFTER REVIEW OF THE PFS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, ADDING THE STEM AND SLEEVE DUE TO THE PREVIOUSLY ALLEGED ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39745 ASR UNI FEMORAL IMPL SIZE 45 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2303788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other