BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK TIBIAL COMPONENT STEMMED PRECOAT

    MDR report key: 7039946 · Received November 16, 2017

    Report

    Report Number
    0002648920-2017-00688
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 23, 2017
    Report Date
    March 6, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: - UNKNOWN NEXGEN LCCK FEMUR. NEXGEN LCCK ARTICULAR SURFACE USE WITH LPS/LPS-FLEX # 00596205012 LOT # 61535121. STEM EXTENSIONS # 00598801215 LOT # 61736623. REPORT SOURCE: - (B)(6). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS EVALUATED THROUGH MANUFACTURING RECORDS, HOWEVER THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE TIBIAL COMPONENT HAD AN IN-VIVO AGE OF SEVEN YEARS. PER THE PACKAGE INSERT, LOOSENING AND INSTABILITY IS LISTED AS KNOWN POTENTIAL ADVERSE EFFECTS. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WIL LBE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION 6 YEARS POST INITIAL SURGERY DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815984 NEXGEN LCCK TIBIAL COMPONENT STEMMED PRECOAT PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A 61588410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R