BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY POSTERIOR STABILIZED ARTICULAR SURFACE

    MDR report key: 5728782 · Received June 16, 2016

    Report

    Report Number
    0001822565-2016-02066
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    May 18, 2016
    Report Date
    August 21, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: CONCOMITANT MEDICAL PRODUCT: LEGACY FEMORAL COMPONENT, CATALOG#: 00599601701, LOT#: 60222922. NONAUGMENTABLE TIBIAL COMPONENT, CATALOG#: 00598605701, LOT#: 60320426. NEXGEN ALL POLY PATELLA, CATALOG#: 00597206535, LOT#: 60206789. THIS DEVICE IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, A SIMILAR DEVICE IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER K960279. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPH PROVIDED. VISUAL ANALYSIS OF OBTAINED PICTURE SHOWS EXISTING WORN HOLE ON THE POSTERIOR LATERAL PORTION OF THE TIBIA AND DEFECTS ON POLY. FROM THE PICTURE PROVIDED BY THE SALES REP, IT APPEARS THAT THE FEMORAL COMPONENT CAUSED THE TIBIAL COMPONENT TO FRACTURE. IT IS LIKELY THAT AFTER WEARING THROUGH THE ARTICULAR SURFACE, THE FEMORAL COMPONENT WAS IN CONTACT WITH THE RAIL OF THE TIBIAL COMPONENT AND THAT LED TO THE TIBIAL COMPONENT FRACTURE. 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(S) IS/ARE REQUIRED. PER THE PACKAGING INSERT FOR LPS KNEE SYSTEM, FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS IS CONSIDERED TO BE A KNOWN ADVERSE EFFECT OF THE PROCEDURE. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 FOR UNKNOWN REASONS AFTER APPROXIMATELY 10 YEARS. DURING THE REVISION, UNUSUAL WEAR WAS NOTED. IT IS REPORTED THAT THE FEMUR WORE THROUGH THE POSTERIOR LATERAL PORTION OF THE ARTICULAR SURFACE AND HAD WORN A HOLE INTO THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383133 NEXGEN LEGACY POSTERIOR STABILIZED ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. N/A 60245835

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R