BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9224400 · Received October 23, 2019

    Report

    Report Number
    1818910-2019-111347
    Event Type
    Injury
    Date Received
    October 23, 2019
    Report Date
    October 4, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. 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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE "FEASIBILITY AND SAFETY OF PERFORMING OUTPATIENT UNICOMPARTMENTAL KNEE ARTHROPLASTY" (2013) BY MICHAEL B CROSS AND RICHARD BERGER PUBLISHED IN INTERNATIONAL ORTHOPAEDICS DOI 10.1007/S00264-013-2214-9 WAS REVIEWED. THE ARTICLE PURPOSE: TO DETERMINE THE FEASIBILITY AND SAFETY OF PERFORMING OUTPATIENT UKAS IN A CONSECUTIVE GROUP OF PATIENTS PRESENTING WITH UNICOMPARTMENTAL KNEE OSTEOARTHRITIS. THE ARTICLE REPORTS: A TOTAL OF 105 CONSECUTIVE PATIENTS FROM JANUARY 2010 TO JANUARY 2013 WHO UNDERWENT UKA WERE RETROSPECTIVELY REVIEWED. NO PATIENTS WERE EXCLUDED FROM THE OUTPATIENT PROTOCOL, AS ALL PATIENTS INDICATED FOR UKA BY THE SENIOR AUTHOR ARE BOOKED AS OUTPATIENT OPERATIONS WITH THE EXPECTATION OF BEING DISCHARGED HOME THE SAME DAY. THE SURGICAL PROCEDURE WAS PERFORMED IN ALL PATIENTS USING A PREVIOUSLY DESCRIBED MINIMALLY INVASIVE, MINI-MIDVASTUS APPROACH. THE IMPLANT USED WAS THE FIXED-BEARING DEPUY SIGMA HIGH PERFORMANCE UKA. ONCE THE PATIENT IS DISCHARGED HOME, VISITING NURSING SERVICES VISIT THE PATIENTS AT HOME (AS THEIR NEEDS REQUIRE), AND ALL PATIENTS UNDERGO HOME PHYSICAL THERAPY UNTIL THEIR FUNCTION ALLOWS THEM TO ATTEND/DRIVE TO OUTPATIENT PHYSICAL THERAPY. ALL PATIENTS WERE FOLLOWED UP AT ONE WEEK, THREE WEEKS AND THREE MONTHS AS PART OF OUR STANDARD POST-OPERATIVE PROTOCOL. NO PATIENTS REQUIRED READMISSION WITHIN THE FIRST WEEK POST-OPERATIVELY. ONE PATIENT REQUIRED READMISSION BETWEEN WEEK ONE AND THREE MONTHS POST-OPERATIVELY. THIS SINGLE PATIENT WHO REQUIRED READMISSION DEVELOPED A POST-OPERATIVE INFECTION REQUIRING IRRIGATION/DEBRIDEMENT WITH POLYETHYLENE LINER EXCHANGE AND INTRAVENOUS ANTIBIOTICS. THERE WERE NO EMERGENCY ROOM (ER) VISITS IN THE FIRST WEEK AFTER SURGERY, NOR WERE THERE ANY ER VISITS RELATED TO THE UNICOMPARTMENTAL REPLACEMENT OR ANY SEVERE SIDE EFFECT FROM THE MEDICATION, PAIN CONTROL, NAUSEA OR ANAEMIA. THERE WERE NO PULMONARY EMBOLISMS, MYOCARDIAL INFARCTIONS OR DEATHS IN THE THREE MONTHS POST SAME-DAY DISCHARGE IN THIS STUDY GROUP. DEPUY PRODUCTS INVOLVED: DEPUY SIGMA HIGH PERFORMANCE. COMPLICATIONS: ONE PATIENT EXPERIENCED INFECTION AND SUBSEQUENT SURGICAL INTERVENTION. CEMENT USAGE AND PATELLA RESURFACING WAS NOT MENTIONED IN THIS ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016407 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention