BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 5

    MDR report key: 9142095 · Received October 1, 2019

    Report

    Report Number
    0002648920-2019-00708
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    May 20, 2019
    Report Date
    March 17, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    UDI-DI
    00889024217607
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI # (B)(4). THIS COMPLAINT IS CONFIRMED. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PHOTOGRAPHS PROVIDED CONFIRMS THAT THE TIBIAL TRAY IS FRACTURED. THE BEARING SHOWS DAMAGE CONSISTENT WITH CONTACT WITH THE FRACTURED TIBIAL COMPONENT. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. X-RAY REVIEW BY MMI CONFIRMS FRACTURE OF THE TIBIAL IMPLANT WITH SUBSIDENCE OF THE FRACTURED MEDIAL TRAY. BONE QUALITY WAS FOUND TO BE OSTEOPENIC WITH MARKED CORTICAL BONE THINNING. A DEFINITIVE 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT(S): 00-5964-017-52 63439144 NEXGEN, FEMORAL COMPONENT; 00-5964-42-12 63313487 NEXGEN, ARTICULAR SURFACE; 00-5988-012-15 63240780 NEXGEN STRAIGHT STEM EXTENSION 15 X 75 MM; 00112114001 16GA18720 HI-FATIGUE BONE CEMENT. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE HOSPITAL WILL NOT ALLOW. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THAT THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE APPROXIMATELY 2 YEARS POST IMPLANTATION. THE PATIENT STARTED EXPERIENCING SEVERE PAIN IN HIS KNEE AND WAS UNABLE TO WALK. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936127 NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 5 PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63464847 00889024217607

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R