BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING

    MDR report key: 7150677 · Received December 28, 2017

    Report

    Report Number
    0001825034-2017-11441
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    December 2, 2017
    Report Date
    January 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE INFORMATION PROVIDED WAS LIMITED. 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). (B)(6). CONCOMITANT MEDICAL PRODUCTS: VANGUARD SERIES-STANDARD PATELLA CAT #: 184766, LOT#: 697270. BIOMET PRIMARY TIBIAL MODULAR TRAY CAT #: 951660, LOT#: 697270. BIOMET MODULAR FINNED STEM CAT #: 141314, LOT#: 806740. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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: 0001825034-2017-11442, 0001825034-2017-11443, 0001825034-2017-11444.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S POST-OPERATIVE OUTCOME IS ABNORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930366 VANGUARD PS TIBIAL BEARING PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 579430

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention