BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF

    MDR report key: 16449046 · Received February 27, 2023

    Report

    Report Number
    0001822565-2023-00526
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 7, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024245006
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL (G04) - PROVISIONAL BOTTOM VISUAL INSPECTION OF THE RETURNED ITEM TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF# (B)(4) LOT # 63366974 FOUND IT TO EXHIBIT SIGNS OF REPEATED USE NICKED / GOUGED AND THE MEDIAL SIDE OF THE TASP HAS FRACTURED OFF. ALL PIECES WERE RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE INSTRUMENT BROKE DURING TRIALING. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658095 TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF INSTRUMENT, KNEE JWH ZIMMER BIOMET, INC. N/A 63366974 00889024245006

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female