BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD SSK 360 FEMORAL COMPONENT

    MDR report key: 7419974 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02516
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 12, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02517-01, 0001825034-2018-02518-01. VISUAL EXAMINATION OF THE RETURNED PACKAGING COMPONENTS CONFIRMED THE REPORTED EVENT AS THE STERILE BLISTER PACKAGING IS CRACKED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. PRODUCT WAS NOT USED DURING SURGERY. THE REPORTED EVENT WAS PREVIOUSLY ADDRESSED AS PART OF A CORRECTIVE ACTION. THE PACKAGING DESIGN CONFIGURATION WAS CHANGED TO ADDRESS THIS ISSUE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(4).CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGE WAS FOUND CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253511 VANGUARD SSK 360 FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 3828402

    Patients

    Seq Age Sex Outcome Treatment
    1