BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEMORAL PEG SET

    MDR report key: 7973242 · Received October 17, 2018

    Report

    Report Number
    0001825034-2018-09758
    Event Type
    Injury
    Date Received
    October 17, 2018
    Report Date
    June 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. X-RAY EVALUATION BY THE THIRD PARTY FOUND THAT THERE IS NORMAL APPEARANCE OF THE RIGHT KNEE ARTHROPLASTY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). MEDICAL PRODUCTS- VANGUARD PS FEMORAL COMPONENT, CATALOG # 183102, LOT # J3714820. BIOMET CC CRUCIATE TRAY, CATALOG # 141232, LOT # J3742220. VANGUARD TIBIAL BEARING, CATALOG # 183624, LOT # 706270. FOREIGN SOURCE- (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09708. 0001825034-2018-09710. 0001825034-2018-09715. OUR INVESTIGATION IS ONGOING. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS NOW EXPERIENCING SEVERE PAIN IN THE RIGHT KNEE. SHE IS ALSO HAVING TROUBLE CLIMBING UP STAIRS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814242 VANGUARD FEMORAL PEG SET PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 033750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other