BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2830335 · Received November 13, 2012

    Report

    Report Number
    1818910-2012-24081
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    January 18, 2013
    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
    FL, 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. (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

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PATIENT FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED EXTREME PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, LOSS OF ENERGY, IMMOBILIZATION, BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND SYSTEMIC INJURIES. PAPERS ALSO ALLEGE EXCESSIVE LEVELS OF CHROMIUM AND COBALT BLOOD LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2172379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other