BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEMMED PRECOAT TIBIAL COMPONENT

    MDR report key: 6174344 · Received December 14, 2016

    Report

    Report Number
    0001822565-2016-04626
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 14, 2016
    Report Date
    October 16, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    PMA / PMN Number
    PN/A
    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

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT IS 1 OF 3 FOR THIS PATIENT: 0001822565-2016-04626/0001822565-2016-04627/0001822565-2016-04628.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION CONCOMITANT MEDICAL PRODUCTS: LPS-FLEX GENDER SOLUTIONS FEMALE(GSF) FEMORAL COMPONENT POROUS LOT#62252405 ITEM#00576201552; PALACOS R+G 1X 40 LOT#77804354 ITEM#66022663; ARTICULAR SURFACE FOR EXPORT ONLY NOT FOR DISTRIBUTION IN THE USA SIZE E 10 MM HEIGHT LOT#62360641 ITEM#00594605010. THE REPORTED EVENT IS CONFIRMED AS THE X-RAYS PROVIDED IDENTIFIED RADIOLUCENCY. PRODUCT WAS NOT RETURNED. RADIOGRAPH REVIEW RELAYED, "RADIOLUCENCY IS PRESENT AT TIBIAL IMPLANT CEMENT-BONE AND METAL-BONE AND CEMENT BONE INTERFACES LATERALLY AND POSTERIORLY, CONSISTENT WITH LOOSENING OF THE TIBIAL COMPONENT. VARUS TILT OF THE TIBIAL TRAY." NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED. DEVICE HISTORY RECORD  (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSEING AFTER A KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823982 NEXGEN FLUTED STEMMED PRECOAT TIBIAL COMPONENT KNEE PROSTHESIS NJL ZIMMER, INC. N/A 62458012

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 66022663, PALACOS R+G 1X40, LOT 77804354