BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 FEMORAL COMPONENT

    MDR report key: 6739816 · Received July 25, 2017

    Report

    Report Number
    0001825034-2017-05119
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    March 23, 2017
    Report Date
    January 17, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    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 REVISION SYSTEM DISTAL FEMORAL AUGMENT WITH BOLT, CAT#: 185462 LOT#: 303970, VANGUARD 360 REVISION SYSTEM DISTAL FEMORAL AUGMENT WITH BOLT, CAT#: 185402 LOT#: 017710, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THE ROOT CAUSE FOR THE REPORTED ISSUE IS ATTRIBUTED TO PATIENT'S CONDITION. 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 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
    519782 VANGUARD 360 FEMORAL COMPONENT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 2744998

    Patients

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