BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL TRAY LOCKING BAR AND SCREW

    MDR report key: 6739837 · Received July 25, 2017

    Report

    Report Number
    0001825034-2017-05128
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    March 23, 2017
    Report Date
    January 18, 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)(6). CONCOMITANT MEDICAL PRODUCTS: 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#: 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 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; 0001825034-2017-05129; 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. 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.

    Additional Manufacturer Narrative · 1

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

    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
    520230 BIOMET 360 TIBIAL TRAY LOCKING BAR AND SCREW PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 375910

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R