BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK 360 DEGREE FEMORAL

    MDR report key: 7258752 · Received February 9, 2018

    Report

    Report Number
    0001825034-2018-00767
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BMT SPLINED KNEE STM 14X80, CATALOG#: 141614 LOT#: 081050, VG 360 DST FM AG 60X10 LL/RM CATALOG#: 185402 LOT#: 371150, VG 360 DST FM AG 60X5 RL/LM CATALOG#: 185302 LOT #: 304320, BMT 360 TIB TRAY 71MM CATALOG #: 185203 LOT#: 502160, BIOMET SMOOTH KNEE STEMS 12X40 CATALOG#: 145002 LOT#: 947140, BMT 360 TIB SM CRUCIATE WING CATALOG#: 185650 LOT#: 012820, BMT 360 2.5MM OFFSET ADAPTER CATALOG#: 185210 LOT#: 827010. 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. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). DATE OF BIRTH: PATIENT'S YEAR OF BIRTH IS (B)(6). MEDICAL PRODUCT: VANGUARD SSK TIBIAL BEARING, CATALOG#: 183886 LOT#: 552610. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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: 0001825034-2018-00767, 0001825034-2018-00768. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT UNDERWENT A PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION. DURING THE PROCEDURE, A PARTIAL OSTEOTOMY OF THE LATERAL BORDER OF THE PATELLA WAS PERFORMED. NO IMPLANTS WERE REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SUFFERED FROM A PATELLOFEMORAL SUBLUXATION AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105411 VANGUARD SSK 360 DEGREE FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 2485451

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R