BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 67.5

    MDR report key: 12391422 · Received August 31, 2021

    Report

    Report Number
    0001825034-2021-02525
    Event Type
    Injury
    Date Received
    August 31, 2021
    Report Date
    October 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G3, G6, H2, H3, H6, AND H10. SWELLING HAS BEEN CONFIRMED BY PHYSICAL THERAPY NOTES AND X-RAY REVIEW. HOWEVER, PAIN CANNOT BE CONFIRMED. REVIEW OF THE PHYSICAL THERAPY NOTES FOUND PAIN AFTER WALKING MORE THAN A MILE AND SWELLING WITH STRENUOUS ACTIVITY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02524, 0001825034-2021-02526, AND 0001825034-2021-02527. MEDICAL DEVICES: BMET ARCOM AP PAT W/WIRE 37MM CATALOG#: 11-150830 LOT#: 079480. BIOMET CC CRUCIATE TRAY 75MM CATALOG#: 141234 LOT#: 620910. E1 VNGD AS TIB BRG 12X75 CATALOG#: EP-189082 LOT#: 505570. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS BEING UNDERGOING PHYSICAL THERAPY APPROXIMATELY ELEVEN YEARS POST IMPLANTATION TO DEAL WITH PAIN AND SWELLING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293197 VANGUARD CR ILOK FEM-RT 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 146930

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10