BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9269882 · Received November 2, 2019

    Report

    Report Number
    1818910-2019-113793
    Event Type
    Injury
    Date Received
    November 2, 2019
    Date of Event
    September 28, 2013
    Report Date
    October 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. 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 WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED "ASSESSING PATIENT-ORIENTED RESULTS AFTER REVISION TOTAL KNEE ARTHROPLASTY." LITERATURE ARTICLE "ASSESSING PATIENT-ORIENTED RESULTS AFTER REVISION TOTAL KNEE ARTHROPLASTY." (2013) BY CLEMENS BAIER ¿ CHRISTIAN LU¨RING ¿ JENS SCHAUMBURGER ¿ FRANZ KO¨CK ¿ JOHANNES BECKMANN ¿ MARKUS TINGART ¿ FLORIAN ZEMAN ¿ JOACHIM GRIFKA ¿ HANS-ROBERT SPRINGORUM PUBLISHED BY THE JOURNAL OF ORTHOPAEDIC SCIENCE DOI 10.1007/S00776-013-0467-1 WAS REVIEWED. THE ARTICLE PURPOSE: TO PRESENT THE OUTCOMES OF A COHORT OF 78 REVISION TKAS THAT WERE EVALUATED USING BOTH RATING SYSTEMS (WOMAC AND KSS). THE ARTICLE REPORTS: THE AUTHORS RETROSPECTIVELY ANALYZED 78 PATIENTS WHO UNDERWENT 78 REVISION TKAS DURING THE YEARS 2003¿2007 WITH AN AVERAGE FOLLOW-UP OF 81 MONTHS. ALL PATIENTS WERE TREATED WITH A STANDARD ROTATING HINGE PROSTHESIS (TC3) DUE TO SIGNIFICANT INSTABILITY. WE EVALUATED THE POSTOPERATIVE RESULTS USING THE KNEE SOCIETY CLINICAL RATING SYSTEM AND THE WOMAC RATING SYSTEM. EVENTUAL CLINICAL RESULTS REVEALED SIGNIFICANT IMPROVEMENTS IN BOTH SCORES. HOWEVER, COMPLICATIONS OCCURRED IN 19 PATIENTS. REOPERATION WAS NECESSARY IN 18 KNEES (26 %). TWO PATIENTS FELL DURING MOBILIZATION. BOTH SUFFERED LIGAMENT DAMAGE AND THE OTHER HAD A FEMORAL FRACTURE (BOTH WERE SUCCESSFULLY TREATED). ONE HAD BONE CEMENT ESCAPE AND UNDERWENT REVISION TO REMOVE THE CEMENT AND EXCHANGE THE TIBIAL TRAY. 4 PATIENTS UNDERWENT REVISION FOR ASEPTIC LOOSENING AND IN ALL 4 PATIENTS ALL COMPONENTS NEEDED TO BE EXCHANGED. DEEP INFECTION OCCURRED IN 3 PATIENTS WHICH WERE ALL SUCCESSFULLY TREATED. ARTHROFIBROSIS WAS SEEN IN 5 PATIENTS WHICH ALL REQUIRED REVISION (ALL WERE SUCCESSFULLY TREATED). ONE PATIENT SUFFERED FROM DEEP VEIN THROMBOSIS. PATELLA RESURFACING WAS NOT ROUTINELY CONDUCTED AND CEMENT WAS USED, BUT THE MANUFACTURER WAS NOT DISCLOSED. DEPUY PRODUCTS INVOLVED: TC3. COMPLICATIONS: TENDON INJURY (1), POST-OPERATION FRACTURE (1), MEDICAL DEVICE REMOVAL (13), ASEPTIC LOOSENING (4), ADHESIONS (5), DEEP VEIN THROMBOSIS (1), SURGICAL INTERVENTION (19).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064595 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention