BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9224305 · Received October 23, 2019

    Report

    Report Number
    1818910-2019-111327
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    January 1, 2016
    Report Date
    October 2, 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, HOWEVER, PHOTOGRAPHS OF THE SUBJECT COMPLAINT SAMPLE WERE PROVIDED FOR REVIEW. NO PRODUCT CONTRIBUTION TO THE REPORTED EVENT WAS IDENTIFIED. 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 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 RECEIVED ENTITLED "CROSSLINK DENSITY IS REDUCED AND OXIDATION IS INCREASED IN RETRIEVED HIGHLY CROSSLINKED POLYETHYLENE TKA TIBIAL INSERTS". LITERATURE ARTICLE "CROSSLINK DENSITY IS REDUCED AND OXIDATION IS INCREASED IN RETRIEVED HIGHLY CROSSLINKED POLYETHYLENE TKA TIBIAL INSERTS" (2016) BY TONG LIU MD, CHRISTINA I. ESPOSITO PHD, JAYME C. BURKET PHD, AND TIMOTHY M. WRIGHT PHD PUBLISHED BY CLINICAL ORTHOPAEDICS AND RELATED RESEARCH DOI 10.1007/S11999-016-4820-5 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE PURPOSE: THIS ARTICLE ATTEMPTS TO BETTER UNDERSTAND THE FOLLOWING TWO QUESTIONS: DOES POLYETHYLENE CROSSLINK DENSITY DECREASE PREFERENTIALLY IN REGIONS OF THE ARTICULAR SURFACE OF THERMALLY STABILIZED CROSSLINKED POLYETHYLENE TIBIAL COMPONENTS EXPOSED TO MECHANICAL STRESS IN VIVO; AND (2) WHAT IS THE RAMIFICATION OF DECREASED CROSSLINK DENSITY IN TKA IN TERMS OF ACCOMPANYING OXIDATION OF THE POLYETHYLENE? THE ARTICLE REPORTS: FROM MAY 2011 TO JANUARY 2014, 90 CROSSLINKED POLYETHYLENE TIBIAL COMPONENTS WERE RETRIEVED DURING REVISION SURGERY AS A PART OF A LONG-STANDING IMPLANT RETRIEVAL PROGRAM. FORTY HIGHLY CROSSLINKED POLYETHYLENE TIBIAL INSERTS (27 POSTERIOR-STABILIZED DESIGNS AND 13 CRUCIATE-RETAINING DESIGNS) RETRIEVED FOR INSTABILITY (FIFTEEN CASES), STIFFNESS (ELEVEN), INFECTION (SIX), ASEPTIC LOOSENING (FOUR), PAIN (TWO), AND MALPOSITION (TWO) AFTER A MEAN TIME OF 18 MONTHS WERE INSPECTED MICROSCOPICALLY TO IDENTIFY LOADED (BURNISHED) AND UNLOADED (UNBURNISHED) REGIONS ON THE ARTICULAR SURFACES. THREE OF THESE TIBIAL INSERTS WERE MADE OF DEPUY XLK POLYETHYLENE. ALL OF THE AFOREMENTIONED ADVERSE EVENTS WERE NOT EXPLICITLY TIED TO THIS DEPUY PRODUCT SO WE WILL CODE AS IF ALL OF THESE ADVERSE EVENTS WERE FOUND IN THE DEPUY PRODUCT. THERE ARE MORE REPORTED ADVERSE EVENTS NOTED THAN THERE ARE DEPUY PRODUCTS FOUND THEREFORE, AT MOST, EACH ADVERSE EVENT COULD HAVE ONLY BEEN FOUND THREE TIMES. THE AUTHORS REPORT THAT WHILE THERE WAS MEASURABLE AMOUNTS OF OXIDATION AND A DECREASE IN CROSSLINK DENSITY NEITHER OF THESE OCCURRED IN AN AMOUNT THAT IS CLINICALLY SIGNIFICANT OR WARRANT "A REASON FOR CONCERN". DEPUY PRODUCTS INVOLVED: XLK POLYETHYLENE TIBIAL INSERT. COMPLICATIONS: INSTABILITY (15), STIFFNESS (11), INFECTION (6), ASEPTIC LOOSENING (4), PAIN (2), AND MALPOSITION (2). CEMENT USAGE AND PATELLA RESURFACING WAS NOT MENTIONED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017989 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention