BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3031612 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-03493
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    June 24, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013-SALES REP REPORTED PATIENT UNDERWENT LEFT HIP REVISION. THE PART/LOT WAS PROVIDED. THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133994 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2533913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other