BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 REVISION SYSTEM DISTAL FEMORAL AUGMENT WITH BOLT

    MDR report key: 6739820 · Received July 25, 2017

    Report

    Report Number
    0001825034-2017-05122
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    March 23, 2017
    Report Date
    January 11, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VANGUARD 360 FEMORAL COMPONENT, CAT#: 185262 LOT#: 2744998, VANGUARD 360 REVISION SYSTEM DISTAL FEMORAL AUGMENT WITH BOLT, CAT#: 185462 LOT#: 303970, VANGUARD 360 REVISION SYSTEM DISTAL FEMORAL AUGMENT WITH BOLT, CAT#: 185342 LOT#: 980270, VANGUARD 360 REVISION SYSTEM POSTERIOR AUGMENT WITH BOLT, CAT#: 185422 LOT#: 829070, BIOMET SPLINED KNEE STEM WITH SCREW, CAT#: 148307 LOT#: 844510, BIOMET 360 OFFSET ADAPTOR WITH SCREWS, CAT#: 185211 LOT#: 707080, BIOMET 360 TIBIAL TRAY LOCKING BAR AND SCREW, CAT#: 185201 LOT#: 375910, BIOMET SPLINED KNEE SYSTEM V2 WITH SCREW, CAT#: 148304 LOT#: 321990, BIOMET 360 OFFSET ADAPTER WITH SCREWS, CAT#: 185211 LOT#: 524230, BIOMET 360 TIBIAL AUGMENT WITH BOLTS, CAT#: 185231 LOT#: 952560, BIOMET 360 TIBIAL AUGMENT WITH BOLTS, CAT#: 185221 LOT#: 320410, VANGUARD CONSTRAINED TIBIAL BEARING, CAT#: 183864 LOT#: 795100. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05119, 0001825034-2017-05121, 0001825034-2017-05122, 0001825034-2017-05123, 0001825034-2017-05124, 0001825034-2017-05125, 0001825034-2017-05126, 0001825034-2017-05128, 0001825034-2017-05129, 0001825034-2017-05130, 0001825034-2017-05134, 0001825034-2017-05135. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS PRODUCT DOES NOT CONTAIN NICKEL, AND THE PATIENT HAS A NICKEL ALLERGY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM A NICKEL ALLERGY AND WAS SUBSEQUENTLY REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519982 VANGUARD 360 REVISION SYSTEM DISTAL FEMORAL AUGMENT WITH BOLT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 017710

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R SEE H10 NARRATIVE