BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SERIES A STANDARD PATELLA

    MDR report key: 6964791 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-09113
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 12, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK140902
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4. MEDICAL PRODUCTS - VANGUARD CR FEMORAL INTERLOK - #183030 LOT # J3960489, UNKNOWN VANGUARD BEARING, VANGUARD MONO FINNED STEMMED TIBIAL TRAY - #166521 LOT # 6026023. REPORT SOURCE: (B)(6). STUDY -(B)(6) (543). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09002. 0001825034-2017-09003. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - VANGUARD CR FEMORAL INTERLOK - #183030 LOT # J3960489, VANGUARD MONO FINNED STEMMED TIBIAL TRAY - #166521 LOT # 6026023. 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. 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 WAS EXPERIENCING VENOUS THROMBOSIS FOUR MONTHS POST INITIAL KNEE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744910 VANGUARD SERIES A STANDARD PATELLA PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 868850

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R