BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE WITH LOCKING SCREW

    MDR report key: 9606562 · Received January 20, 2020

    Report

    Report Number
    0001822565-2020-00223
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    January 10, 2020
    Report Date
    July 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024225268
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EVALUATION OF THE RETURNED ARTICULAR SURFACE SHOWS SIGNS OF USE. HOWEVER, LOCKING SCREW INVOLVED IN THESE EVENT WAS NOT RETURNED; THEREFORE, NO FURTHER EVALUATION CAN BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT 87-6203-453-23: 'LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES' IS KNOWN ADVERSE EFFECT OF THE SYSTEM. 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). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 A PATIENT WAS REVISED DUE TO THE LOCKING SCREW BEING LOOSE. ACCORDING TO SURGEON DURING REVISION THEY SAW THAT THE SCREW LOOKED "COMPRESSED". THEY TRIED TO CHANGE THE INSERT AND INSERT A NEW LOCKING SCREW. WHEN THEY TIGHTENED IT WITH THE LCCK MOMENTUM KEY THE SCREW FRACTURED. THEY DECIDED TO DO A TOTAL REVISION AND REVISED ALL COMPONENTS. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69318 ARTICULAR SURFACE WITH LOCKING SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 63422524 00889024225268

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R