BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN FEMORAL INTERLOCK

    MDR report key: 6958054 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-08710
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 13, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET OFFSET TIBIAL TRAY CAT#: 141482, LOT#: 127930 BIOMET OFFSET TIBIAL TRAY ADAPTOR CAT#: 141490, LOT#: 955680 BIOMET OFFSET TIBIAL TRAY ADAPTOR CAT#: 141491, LOT#: 645930 BIOMET SPLINED KNEE STEM CAT#: 141610, LOT#: 661680 MAXIM MODULAR TIBIAL BLOCK WITH SCREWS CAT#: 141762, LOT#: 589970 VANGUARD DCM PS TIBIAL BEARING CAT#: 183622, LOT#: 300920 BIOMET SERIES STANDARD PATELLA CAT#: 184704, LOT#: 302200. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034 - 2017 - 08709, 0001825034 - 2017 - 08710. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 APPROXIMATELY TEN YEARS AFTER INITIAL KNEE ARTHROPLASTY THE PATIENT UNDERWENT A REVISION DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737781 VANGUARD PS OPEN FEMORAL INTERLOCK PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 014900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R