BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4

    MDR report key: 11528511 · Received March 19, 2021

    Report

    Report Number
    0001822565-2021-00785
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: ARTICULAR SURFACE SIZE EF 10 MM HEIGHT, ITEM# 00596203210, LOT# 61447452. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ZONE OF PERIPROSTHETIC LUCENCY BETWEEN THE TIBIAL STEM TIP AND CEMENT/BONE MAY INDICATE LOOSENING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT 87-6203-453-01, LOOSENING IS A 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 · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TEN YEARS AND TEN MONTHS¿ POST IMPLANTATION DUE TO TIBIAL LOOSENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428830 STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 61390963

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R