BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 4 HI OFFSET

    MDR report key: 2944329 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-03784
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    June 15, 2012
    Report Date
    January 15, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    PMA / PMN Number
    K073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. **UPDATE** (B)(6) 2012: LITIGATION DOCUMENTS WERE RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN, STIFFNESS, DISCOMFORT, EXCESSIVE LEVELS OF CHROMIUM AND COBALT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTS THE PATIENT'S MOBILITY AND QUALITY OF LIFE. THE PATIENT'S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN CONSEQUENTLY LIMITED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE**(B)(6) 2013-MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATED CORROSION. THE SLEEVE AND STEM WERE ADDED TO THE COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48174 TRI-LOCK BPS SZ 4 HI OFFSET STEM KWA DEPUY WARSAW DN9D41

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention