BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD ANTERIOR STABILIZED TIBIAL BEARING

    MDR report key: 6951638 · Received October 16, 2017

    Report

    Report Number
    0001825034-2017-08471
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 2, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. X-RAY REVIEW: OVERALL FIT AND ALIGNMENT OF RIGHT TOTAL KNEE ARTHROPLASTY IMPLANTS APPEAR STANDARD. BONE QUALITY CANNOT BE EVALUATED DUE TO POOR IMAGE QUALITY. THE X-RAYS SUBMITTED DO NOT CONFIRM INSTABILITY OF THE RIGHT KNEE. DEVICE HISTORY RECORD 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VANGUARD CRUCIATE RETAINING ILOK FEMORAL, CAT#: 183014 LOT#: J3717866, BIOMET COBALT CHROMIUM CRUCIATE TRAY, CAT#: 141236 LOT#: J3718777, SERIES-A PATELLA, CAT#: 184788 LOT#: 511510, COBALT BONE CEMENT, CAT#: 402283 LOT#: 865330, COBALT BONE CEMENT, CAT#: 402283 LOT#: 926030. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT IS BEING RETAINED AT THE HOSPITAL. 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. NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730775 VANGUARD ANTERIOR STABILIZED TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 547220

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R