BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3072956 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-04864
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 18, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY 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.

    Description of Event or Problem · 1

    LEGAL CLAIM ALLEGES DEVICES WERE REMOVED FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. **UPDATE** (B)(4) 2013 - LITIGATION RECEIVED (B)(4) 2013 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. LITIGATION ALLEGES PATIENT HAD PAIN, DISABILITY AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT. DOB ADDED. DOI: (B)(6) 2008. DOR: NONE REPORTED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. PRODUCT HIP CHANGED TO CUP, ADDED PRODUCT HEAD AND REPORTED BOTH. **UPDATE** (B)(4) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND SIDE. 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

    LITIGATION ALLEGES PATIENT HAD PAIN, DISABILITY AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174435 ASR UNI FEMORAL IMPL SIZE 51 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2441720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other