BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM- PS CLSD INTLK FEM-RT 67.5

    MDR report key: 6501008 · Received April 18, 2017

    Report

    Report Number
    0001825034-2017-02633
    Event Type
    Injury
    Date Received
    April 18, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM: COCR I-BEAM TRAY 67MM, CATALOG NUMBER: 141222, LOT: J3872064, ITEM: SERIES A PATELLA 28MM, CATALOG NUMBER: 184762, LOT: 273320, ITEM: VANGUARD PS TIBIAL BEARING, CATALOG NUMBER: 183620, LOT: 141380. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02634/02635/02636. ZIMMER BIOMET REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    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. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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 NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 A PATIENT WHO UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY SIX MONTHS AGO HAS BEEN BEEN EXPERIENCING PAIN IN THE HIP, LEG, AND GROIN ALONG WITH STIFFNESS. NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WHO UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY SIX MONTHS AGO HAS BEEN BEEN EXPERIENCING PAIN IN THE HIP, LEG, AND GROIN ALONG WITH STIFFNESS. NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT WAS ALSO EXPERIENCING SWELLING AND WARM TO THE TOUCH ON HIS KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282653 VANGUARD COMPLETE KNEE SYSTEM- PS CLSD INTLK FEM-RT 67.5 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 752790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R