BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 7288409 · Received February 22, 2018

    Report

    Report Number
    1818910-2018-53894
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    January 30, 2018
    Report Date
    January 30, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DER STATES THAT THE PATIENT RECEIVED A CEMENTED DEPUY SIGMA CRUCIATE LTK IN 2013. THEY WERE SUBSEQUENTLY INVOLVED IN AN MVA THAT CAUSED THE FEMORAL COMPONENT TO LOSS ITS BONE FIXATION AND BECAME PAINFUL. THE PATIENT THEN WAS REVISED TO A CEMENTED SIGMA P5 FEMORAL COMPONENT AND CRUCIATE SCARIFYING ARTICULATING SURFACE. THE TIBIAL TRAY AND PATELLA WERE RETAINED AT THE TIME OF SURGERY 18 MONTHS POST OP THIS SAME KNEE BECAME STIFF AND PAINFUL. IT WAS DETERMINED THAT THE FEMORAL BONE SURROUNDING THE ANTERIOR SECTION OF THE KNEE WAS RESORBING. THE FEMORAL COMPONENT WAS REVISED TO A SIGMA TC3 COMPONENT WITH A STEM AND AUGMENTS. THE ARTICULATING SURFACE WAS ALSO INCREASED TO A THICKER SIZE. PATELLA AND TIBIAL TRAY WERE RETAINED. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132098 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention