BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL

    MDR report key: 7635473 · Received June 25, 2018

    Report

    Report Number
    0001822565-2018-03103
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    April 12, 2018
    Report Date
    July 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    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 · 0

    VOIDING DUE TO INCORRECT MFR NUMBER. THIS EVENT WILL BE REPORTED UNDER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN IMPLANT DATE IN 2008. CONCOMITANT PRODUCTS: 00-5952-015-02 CR-FLEX POROUS FEMORAL SIZE E/RT; 00-5952-030-12 ARTICULAR SURFACE 3, 4/YELLOW 12MM (FEM C-H ¿ TIB 3, 4); 00-5972-065-35 ALL-POLY PATELLA, 35MM X 9.0MM. A PICTURE OF THE DEVICE WAS PROVIDED AND EXAMINATION DETERMINED THAT THERE IS BLOOD AND FOREIGN MATERIAL ON BOTH SUPERIOR AND INFERIOR SIDE OF THE TIBIAL COMPONENT. THERE WAS LESS CEMENT OBSERVED ON THE INFERIOR SIDE OF THE TIBIAL PLATE. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO ANOMALIES/DEVIATIONS IDENTIFIED. SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHIC IMAGING CONFIRMS LOOSENING OF THE TIBIAL COMPONENT. POSSIBLE CONTRIBUTING FACTORS FOR TIBIAL COMPONENT LOOSENING INCLUDE OSTEOPENIA, EXCESSIVE POSTERIOR CEMENT AND PAUCITY OF CEMENT UNDERLYING THE MEDIAL TIBIAL TRAY. THE TIBIAL TRAY CURRENTLY EXHIBITS VARIOUS MALALIGNMENT; HOWEVER, IT IS UNKNOWN IF THERE HAS BEEN MIGRATION/SUBSIDENCE SINCE THE SURGICAL IMPLANTATION. BONE QUALITY APPEARS OSTEOPENIC. ROOT CAUSE CANNOT BE DETERMINED. 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. HOSPITAL DISCARDED AS BIOHAZARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO TIBIA COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476105 NEXGEN STEMMED TIBIAL KNEE PROTHESIS JWH ZIMMER BIOMET, INC. N/A 60931596

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R