BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 SSK DISTAL FEMORAL AUGMENT

    MDR report key: 7120486 · Received December 15, 2017

    Report

    Report Number
    0001825034-2017-11092
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    July 11, 2017
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE FOREIGN: (B)(6). CONCOMITANT MEDICAL PRODUCTS: VANGUARD DCM TIBIAL BEARING CAT#: 183862, LOT#: 413770. VANGUARD SSK 360 FEMORAL WITH SCREW CAT#: 185283, LOT#: 2780385. BIOMET 360 TIBIAL TRAY WITH TI LOCKING BAR AND SCREW CAT#: 185201, LOT#: 489420. BIOMET SMOOTH KNEE STEM WITH SCREW CAT#: 145026, LOT#: 974240. BIOMET 360 OFFSET ADAPTOR WITH SCREW CAT#: 185212, LOT#: 869810. VANGUARD 360 SSK POSTERIOR FEMORAL AUGMENT CAT#: 185343, LOT#: 675300. VANGUARD 360 SSK DISTAL FEMORAL AUGMENT CAT#: 185403, LOT#: 675300. BIOMET SMOOTH KNEE STEM CAT#: 145004. BIOMET 360 OFFSET ADAPTOR WITH SCREW CAT#: 185212, LOT#: 869810. BIOMET 360 TIBIAL AUGMENT CAT#: 185221, LOT#: 147150. BIOMET 360 TIBIAL AUGMENT WITH BOLTS CAT#: 185221, LOT#: 2577939. UNKNOWN BIOMET KNEE PATELLA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 - 11086, 0001825034 - 2017 - 11087, 0001825034 - 2017 - 11088, 0001825034 - 2017 - 11089, 0001825034 - 2017 - 11090, 0001825034 - 2017 - 11091, 0001825034 - 2017 - 11092 , 0001825034 - 2017 - 11093, 0001825034 - 2017 - 11094, 0001825034 - 2017 - 11095, 0001825034 - 2017 - 11096, 0001825034 - 2017 - 11097, 0001825034 - 2017 - 11098.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE IS NO INDICATION THAT PATIENT HAS ANY ZIMMER BIOMET COMPONENTS IMPLANTED INTO THE RIGHT KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT TWO YEARS AFTER INITIAL LEFT KNEE ARTHROPLASTY DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899362 VANGUARD 360 SSK DISTAL FEMORAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 120300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R