BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 3 STD OFFSET

    MDR report key: 2792647 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-21894
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    June 29, 2011
    Report Date
    September 21, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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). 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

    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 REVISED FOR PAIN, INFLAMMATION, AND HIGH ION LEVELS. UPDATE: (B)(6) 2012- LEGAL CLAIM AND MEDICAL RECORDS RECEIVED. IN ADDITION TO PREVIOUSLY REPORTED ALLEGATIONS, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM INSTABILITY, ASEPTIC LOOSENING, METALLOSIS, AND A SMALL AMOUNT OF CORROSION. THE STEM AND SLEEVE HAVE BEEN ADDED AND ALL PRODUCTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-LOCK BPS SZ 3 STD OFFSET STEM KWA DEPUY INTERNATIONAL CX9CH1000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention