BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 14 MM THICKNESS

    MDR report key: 7746423 · Received August 3, 2018

    Report

    Report Number
    0001822565-2018-04162
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Report Date
    February 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED TASP SHIM EXHIBITS SIGNS OF REPEATED USE (NICKED OR GOUGED) AND HAS BOTH OF COMPONENTS 1 AND 2 DISASSEMBLED / MISSING. THE MISSING COMPONENTS WERE NOT RETURNED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO DESIGN DEFICIENCY. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 04165 - 1, 0001822565 - 2018 - 04166 - 1, 0001822565 - 2018 - 04168 - 1, 0001822565 - 2018 - 04169 - 1, 0001822565 - 2018 - 04170 - 1 AND 0001822565 - 2018 - 04171 - 1.

    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001822565 - 2018 - 04162, 0001822565 - 2018 - 04165, 0001822565 - 2018 - 04166, 0001822565 - 2018 - 04168, 0001822565 - 2018 - 04169, 0001822565 - 2018 - 04170, 0001822565 - 2018 - 04171.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ROUTINE INSPECTION, IT WAS DISCOVERED THE INSTRUMENTS WERE WORN AND WHEN RETURNED; SHIMS ARE MISSING THE BEARING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587813 TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 14 MM THICKNESS PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62786964

    Patients

    Seq Age Sex Outcome Treatment
    1