BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE

    MDR report key: 11087029 · Received December 29, 2020

    Report

    Report Number
    0001822565-2020-04235
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 14, 2020
    Report Date
    March 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K042271
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: H6 (HEALTH EFFECT- IMPACT CODE AND CLINICAL CODE) VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF BEING IN-VIVO, WEAR, AND DISCOLORATION. THE POST WAS FRACTURED. THE DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. THE ANALYSIS DETERMINED THE POST-FRACTURE WAS THE RESULT OF OVERLOADING OF THE BEARING SURFACE PARTICULARLY ON THE POST, AND POSSIBLY EXACERBATED BY IMPINGEMENT DAMAGE, LEADING TO CRACK PROPAGATION. RADIOGRAPHS WERE PROVIDED AND NOT REVIEWED BY A HEALTH CARE PROFESSIONAL. 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, FRACTURE OF THE IMPLANT IS A KNOWN ADVERSE EFFECT OF THE PROCEDURE. 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 PATIENT WAS REVISED APPROXIMATELY NINE YEARS AND THREE WEEKS POST IMPLANTATION DUE TO IMPLANT FRACTURE. THE PATIENT COMPLAINED OF KNEE LOCKING AND DIAGNOSTIC ARTHROSCOPY WAS PERFORMED WHICH IDENTIFIED THE POST ON THE ARTICULAR SURFACE HAD FRACTURED CLEAN OFF. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554696 ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 60942985

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R