BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 REVISION KNEE SYSTEM - FEMORAL FLAT AUGMENTS

    MDR report key: 6421953 · Received March 21, 2017

    Report

    Report Number
    0001825034-2017-00862
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    January 27, 2017
    Report Date
    June 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. DEVICE WAS NOT RETURNED SO PRODUCT EVALUATION COULD BE CONDUCTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN ASSOCIATED RISK DOCUMENTATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: LOCKING BAR, ITEM: 141205, LOT: 373750. ITEM NAME: VANGUARD ANTIXIDANT POLY AS E1 TIBIAL BEARING 18 X 75, ITEM: EP189088, LOT: 241400. ITEM NAME: VANGUARD CR ILOK FEMORAL RIGHT 70, IT183012, LOT: J3845943. ITEM NAME: VANGUARD 360 PST FEMORAL AUGMENT 70X10, ITEM: 185426, LOT:157710. ITEM NAME: SERIES A 3 PEG STANDARD PATELLA 31X8, ITEM: 184764, LOT: 230600. ITEM NAME: COCR FINNED TIBIAL TRAY 75MM, ITEM: 141234, LOT: J3868067. ITEM NAME: PALACOS RG 1X40, ITEM: 00111314001, LOT: 83194475. ITEM NAME: PALACOS RG 1X40, ITEM: 00111314001, LOT: 83194475. THIS REPORT IS NUMBER 1 OF 12 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00859/00860/00861/00862/00863/00865/00866/00867/00869/00870, 0001822565-2017-01114/01115). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT THE FIRST PART OF A TWO-STEP REVISION APPROXIMATELY 3 WEEKS POST-IMPLANTATION DUE TO INFECTION. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE COMPONENTS FROM THE PATIENT'S TOTAL KNEE ARTHROPLASTY WERE REMOVED APPROXIMATELY 2 MONTHS POST OPERATIVE TO DO A TWO STEP TREATMENT FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205037 VANGUARD 360 REVISION KNEE SYSTEM - FEMORAL FLAT AUGMENTS PROTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 242690

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R