BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9489034 · Received December 18, 2019

    Report

    Report Number
    1818910-2019-123758
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    February 13, 2014
    Report Date
    December 3, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    THE LITERATURE ARTICLE ENTITLED, "CAN TRANEXAMIC ACID AND HYDROGEN PEROXIDE REDUCE BLOOD LOSS IN CEMENTED TOTAL KNEE ARTHROPLASTY?" WRITTEN BY JERRY YONGQIANG CHEN, INDERJEET SINGH RIKHRAJ, ZHIHONG ZHOU, DARREN KENG JIN TAY, PAK LIN CHIN, SHI-LU CHIA, NGAI NUNG LO, AND SENG JIN YEO PUBLISHED BY ARCH ORTHOP TRAUMA SURG (2014)134:997-1002 DOI 10.1007/S00402-014-1958-Z PUBLISHED ONLINE 13 FEBRUARY 2014 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO EVALUATE THE EFFECTIVENESS OF INTRA-ARTICULAR TXA AND H2O2 IN REDUCING BLOOD LOSS DURING TKA. ALL IMPLANTS UTILIZED WERE DEPUY PRODUCTS. CEMENT MANUFACTURER IS NOT IDENTIFIED. PATELLA RESURFACING WAS NOT PERFORMED. DATA WAS COMPILED FROM 150 PATIENTS DIVIDED IN 3 DIFFERENT GROUPS RECEIVING IMPLANTS BETWEEN MAY 2011 AND DECEMBER 2011. DEPUY PRODUCTS UTILIZED: SIGMA FIXED BEARING KNEE SYSTEM. ADVERSE EVENTS: ONE MYOCARDIAL INFARCTION, ONE PULMONARY EMBOLISM, ONE DEEP VEIN THROMBOSIS AND 4 CARDIAC ARRHYTHMIA. THE ARTICLE DOES NOT PROVIDE INTERVENTION INFORMATION FOR THE ADVERSE EVENTS AND IT DOES NOT PROVIDE ADEQUATE INFORMATION TO DETERMINE ACCURATE QUANTITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285543 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS, INC. 1818910 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention