BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 4 STD OFFSET

    MDR report key: 3072996 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-06596
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    DEPUY SUZHOU
    Product Code
    KWA
    PMA / PMN Number
    K073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(6) 2013 - PATIENTS REVISION OPERATIVE RECORDS WERE RECEIVED. UPON REVISION, CLEAR COLORED FLUID WITH SOME DEBRIS WAS FOUND IN THE CAPSULE. ALSO NOTED WAS A METAL STAINED CAPSULE AND CORROSION ON THE TRUNNION OF THE FEMORAL COMPONENT. THE STEM AND SLEEVE WERE ADDED TO THE COMPLAINT AND THE COMPLAINT WAS RE-OPENED. DOR: (B)(6) 2013 (RIGHT HIP). EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED REGARDING THE REPORTED STEM CORROSION. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PATIENTS REVISION OPERATIVE RECORDS WERE RECEIVED. UPON REVISION, CLEAR COLORED FLUID WITH SOME DEBRIS WAS FOUND IN THE CAPSULE. ALSO NOTED WAS A METAL STAINED CAPSULE AND CORROSION ON THE TRUNNION OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175443 TRI-LOCK BPS SZ 4 STD OFFSET STEM KWA DEPUY SUZHOU DX6FJ1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention