BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE SIZE EF 9 MM HEIGHT (5.5 MM UNDER THE CONDYLES)

    MDR report key: 10158466 · Received June 16, 2020

    Report

    Report Number
    0001822565-2020-02100
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024405394
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DOVETAIL FEATURE WAS FLARED OUT AND EXHIBITS SIGNS OF USE (NICKED OR GOUGED). EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE DEVICE WOULD NOT SEAT AS THE DOVETAIL FEATURE WAS DAMAGED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. DETAILED INSTRUCTIONS FOR INSERTING THE ARTICULAR SURFACE ARE PROVIDED IN LPS-FLEX FIXED BEARING KNEE SURGICAL TECHNIQUE (97-5964-102-00-REV0616) PG. 15-17. 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). 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 AN ARTICULAR SURFACE WOULD NOT SEAT TO THE TIBIAL TRAY. IT WAS REMOVED AND VISUALLY ASSESSED RESULTING IN REQUIREMENT FOR REPLACEMENT. THERE WERE NO OBSERVED PROBLEMS WITH THE AS APPLICATION AND INSERTION TECHNIQUE DEPLOYED BY THE SURGEONS. A NEW ARTICULAR SURFACE WAS OPENED, AND WAS ABLE TO BE IMPLANTED INTO THE PATIENT WITHOUT ANY OF THE ABOVE MENTIONED PROBLEMS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623420 ARTICULAR SURFACE SIZE EF 9 MM HEIGHT (5.5 MM UNDER THE CONDYLES) PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64535030 00889024405394

    Patients

    Seq Age Sex Outcome Treatment
    1