BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 7140960 · Received December 21, 2017

    Report

    Report Number
    0002648920-2017-00775
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 24, 2017
    Report Date
    May 24, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. CHIPPED OFF FRAGMENT OF THE TIBIAL COMPONENT WAS RETURNED AND EXAMINATION OF THE RETURNED CHIP DETERMINED THAT FRACTURE SHOWED INDICATIONS OF OVERLOAD OF FRACTURE BY EXHIBITING DUCTILE DIMPLES. SUSPECTED FRACTURE INITIATION SITE WAS IDENTIFIED AND EDS ELEMENTAL ANALYSIS SHOWS THAT THE CHIP WAS CONSISTENT WITH TI-6AL-4V ALLOY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: NEXGEN FEMORAL COMPONENT, CATALOG #: 00596401751 LOT #: 63653421. NEXGEN ARTICULAR SURFACE, CATALOG #: 00596405014 LOT #: 62569642. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE IMPLANT FRACTURED DURING IMPLANTATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919711 NEXGEN STEMMED TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 62665928

    Patients

    Seq Age Sex Outcome Treatment
    1