BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM

    MDR report key: 10579807 · Received September 24, 2020

    Report

    Report Number
    0001822565-2020-03350
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 26, 2020
    Report Date
    November 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113369
    Removal / Correction Number
    ZFA 2014-67, Z-1052-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORDS FOR ITEM# 42527900502, LOT# 62357316 & RECEIVING INSPECTION REPORT ITEM# 42527950502, LOT# 80560124, 80560149 WERE REVIEWED FOR DEVIATIONS AND / OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. REFERENCE CAPA 997 VERIFIED ITEM LOT COMBINATION AND REVIEWED MANUFACTURING DATE AS TASP LOT 62357316 EXHIBITS SIGNS OF REPEATED USE (NICKED OR GOUGED) AND HAS ONE OF COMPONENTS 1 AND 2 DISASSEMBLED / MISSING. THE MISSING COMPONENT WAS NOT RETURNED. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE IS CONFIRMED TO HAVE BEEN A PART OF THE CAPA 997 INVESTIGATION. FIELD ACTION ZFA (B)(4) WERE INITIATED TO RECOMMEND AGAINST USING ULTRASONIC CLEANING AS A STERILIZING TECHNIQUE FOR THESE DEVICES. THESE DEVICES WERE SUBSEQUENTLY RE-DESIGNED TO ACCOUNT FOR THIS FAILURE MODE WITH A NEW LOCKING MECHANISM. IT WAS DETERMINED THAT THESE DEVICES WERE MANUFACTURED PRIOR TO THIS DESIGN CHANGE. THE ROOT CAUSE IS CONSIDERED TO BE A PREVIOUSLY ADDRESSED DESIGN ISSUE. CAPA 997 WAS PREVIOUSLY INITIATED TO FURTHER EVALUATE THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT

    Additional Manufacturer Narrative · 1

    (B)(4). 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 · 1

    IT WAS REPORTED A TRIAL ARTICULAR SURFACE WAS RETURNED MISSING BEARINGS ON A WORN INSTRUMENT CLAIM FORM. ALL PIECES HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048520 TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM PROSTHESEIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62357316

    Patients

    Seq Age Sex Outcome Treatment
    1