BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 8185353 · Received December 20, 2018

    Report

    Report Number
    0001822565-2018-07035
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Report Date
    March 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PART DETERMINED THAT RETURNED TASP EXHIBITS SIGNS OF REPEATED USE (NICKED OR GOUGED) AND IS FRACTURED ON MEDIAL SIDE OF POST, ALL PIECES 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 - 07034 - 1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: TIBIAL ARTICULAR SURFACE PROVISIONAL; P/N: 42527900700, L/N: 62377739, TIBIAL ARTICULAR SURFACE PROVISIONAL; P/N: 42517000505, L/N: 62698724. 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. 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 - 07034, 0001822565 - 2018 - 07035.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INSPECTION THAT THE DEVICE WAS WORN. SUBSEQUENTLY, THE DEVICE WAS WORN AND FRACTURED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022749 TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62698724

    Patients

    Seq Age Sex Outcome Treatment
    1