BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING

    MDR report key: 8210123 · Received January 2, 2019

    Report

    Report Number
    0001825034-2019-00006
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO PATIENT CONDITION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00002, 0001825034 - 2019 - 00005, 0001825034 - 2019 - 05275, 0001825034 - 2019 - 05278, 0001825034 - 2019 - 05279, 0001825034 - 2019 - 05280, 0001825034 - 2019 - 05281, 0001825034 - 2019 - 05282, 0001825034 - 2019 - 05283, 0001825034 - 2019 - 05284.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- VANGUARD INTERLOK FEMORAL COMPONENT, CATALOG # 183326, LOT # 156230, BIOMET INTERLOK STEM TIBIAL COMPONENT, CATALOG # 141513, LOT # 357860, BIOMET POROUS FINN STEM, CATALOG # CP163826, LOT # 784950, VANGUARD POST FEMORAL AUGMENT, CATALOG # 184226, LOT # 861350, BIOMET TIBIAL BLOCK, CATALOG # 141763, LOT # 959760, VANGUARD AUGMENT BOLT, CATALOG # 184299, LOT # 861460, VANGUARD POST FEMORAL AUGMENT, CATALOG # 184246, LOT # 258970, VANGUARD DISTAL FEMORAL AUGMENT, CATALOG # 184266, LOT # 677130, VANGUARD DISTAL FEMORAL AUGMENT, CATALOG # 184286, LOT # 677160, BIOMET POROUS FINN STEM, CATALOG # CP163816, LOT # 799930. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00002, 0001825034-2019-00005. 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 AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS DEVELOPED AN ALLERGY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871 VANGUARD PS TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI  

    Patients

    Seq Age Sex Outcome Treatment
    1 Other