BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK TI 13.8 LAT OFFSET

    MDR report key: 2973728 · Received February 22, 2013

    Report

    Report Number
    1818910-2013-12728
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWL
    PMA / PMN Number
    PK872878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    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

    (B)(4). DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Description of Event or Problem · 1

    UPDATE REC¿D 01/04/2017 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALSO ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT, STIFFNESS, DECREASED RANGE OF MOTION, DIFFICULTY ROTATING HIP, DIFFICULTY BEARING WEIGHT, AND DIFFICULTY AMBULATING.

    Description of Event or Problem · 1

    UPDATE MAY 03, 2017: LEGAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED ON THE OPERATIVE NOTES THAT THERE WAS A SIGNIFICANT RADIOLUCENCIES HAVE DEVELOPED AROUND THE PROXIMAL ASPECT OF HIS FEMORAL COMPONENT AND IT APPEARS TO HAVE SUBSIDED IN ADDITION, FEMORAL COMPONENT LOOSENING CONFIRMED INTRAOPERATIVELY. IDENTIFIED A ¿MODERATE AMOUNT OF BONE RESORPTION¿ OF THE PROXIMAL FEMUR. THERE WAS ¿DENSE FIBROUS INGROWTH INTO THE DISTAL ASPECT OF THE POROUS COATING¿ OF THE FEMORAL COMPONENT. REVIEW OF SERUM COBALT AND CHROMIUM LEVELS FROM 10/8/2012 DEMONSTRATES NORMAL VALUES. THERE IS NO EVIDENCE OF METALLOSIS. THIS COMPLAINT WAS UPDATED ON: MAY 9, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77736 TRI-LOCK TI 13.8 LAT OFFSET HIP FEMORAL STEM/SLEEVE KWL DEPUY ORTHOPAEDICS INC US B53E51000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention