BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD INTERLOK TIBIAL TRAY

    MDR report key: 7525855 · Received May 18, 2018

    Report

    Report Number
    0001825034-2018-03453
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    April 24, 2018
    Report Date
    September 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: ARCOM SERIES-A STANDARD PATELLA, CATALOG #: 184768, LOT #: 143010; VANGUARD INTERLOK FEMORAL COMPONENT, CATALOG #: 195923, LOT #: 244690; VANGUARD XP LATERAL TIBIAL BEARING, CATALOG #: 195822, LOT #: 641550; VANGUARD XP MEDIAL TIBIAL BEARING, CATALOG #: 195563, LOT #: 091950. 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: 0001825034-2018-03451; 0001825034-2018-03452; 0001825034-2018-03453; 0001825034-2018-03454; 0001825034-2018-03455. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DATE OF EVENT WAS PREVIOUSLY REPORTED (B)(6) 2018, DATE OF THE EVENT WAS ON AN UNKNOWN DAY IN (B)(6) 2017. 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 PATIENT HAD DEVELOPED A HEMATOMA. THE PATIENT WAS UNABLE TO PERFORM PHYSICAL THERAPY, WHICH LEAD TO MORE ISSUES SUCH AS A LATERAL RELEASE FOR PATELLA ALIGNMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367272 VANGUARD INTERLOK TIBIAL TRAY PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 841560

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other