BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK TI 11.3 LAT OFFSET

    MDR report key: 6032720 · Received October 16, 2016

    Report

    Report Number
    1818910-2016-29594
    Event Type
    Injury
    Date Received
    October 16, 2016
    Date of Event
    October 8, 2013
    Report Date
    September 20, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWL
    PMA / PMN Number
    K872878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    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. (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

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE: 10/03/2016 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION SURGERY NOTES REPORT SYNOVITIS, MALAISE, FATIGUE, AND SOME CARDIAC IRREGULARITIES. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, SORENESS, STIFFNESS, SWELLING, DISCOMFORT, INCREASED METAL ION LEVELS, AND INFLAMMATION. PATIENT IS BILATERAL. DOI AND DOR THE SAME FOR BOTH HIPS. UPDATE REC'D 07/25/2014 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED LOT INFORMATION FROM PATIENT STICKER SHEET. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE (B)(6) 2016 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, ELEVATED METAL ION LEVELS WERE REPORTED (WITH NO ACTUAL VALUE GIVEN). ADDING STEM /SLEEVE. THE COMPLAINT WAS UPDATED ON: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684149 TRI-LOCK TI 11.3 LAT OFFSET HIP FEMORAL STEM/SLEEVE KWL DEPUY ORTHOPAEDICS, INC. CG4AL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention