BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 5 STD OFFSET

    MDR report key: 3103432 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-05447
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    February 2, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2009. SINCE HER SURGERY, PATIENT HAS EXPERIENCED GROIN PAIN, HIP PAIN, COMPONENT MALALIGNMENT AND PROBLEMS SITTING AND STANDING AND WALKING. PATIENT HAS NOT YET SCHEDULED A REVISION SURGERY. UPDATE A REVIEW OF THE PATIENTS MEDICAL RECORDS REVEALED THE PATIENT SUFFERED A CALCAR FRACTURE DURING PRIMARY IMPLANTATION UPON INSERTION OF THE FINAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203849 TRI-LOCK BPS SZ 5 STD OFFSET FEMORAL STEM HIP IMPLANT KWA DEPUY WARSAW C97B71000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other