BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK 360 FEMUR R 67.5

    MDR report key: 7744549 · Received August 2, 2018

    Report

    Report Number
    0001825034-2018-05483
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    July 6, 2018
    Report Date
    May 7, 2019
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE X-RAYS BY A THIRD PARTY STATE THAT THE CEMENTED COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS NO FRACTURE OR EVIDENCE OF COMPONENT LOOSENING. THERE IS A SUBTLE METALLIC DENSITY OVERLYING THE MEDIAL ASPECT OF THE FEMORAL NOTCH THAT COULD REPRESENT THE DESCRIBED "BACKED OUT" FEMORAL SCREW. HOWEVER, THIS CANNOT BE CONFIRMED AS IT IS NOT SEEN ON THE LATERAL VIEW. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET SPLINED KNEE STEM, CATALOG # 148308, LOT # 277810; PALACOS BONE CEMENT, CATALOG # 00111214001, LOT # 78884388; BIOMET 360 TIB SM CRUCIATE WING, CATALOG # 185650, LOT # 810610; BIOMET 360 TIB OFFSET ADAPTER, CATALOG # 185211, LOT # 045340; BIOMET SERIES A PATELLA, CATALOG # 184788, LOT # 502720; BIOMET SPLINED KNEE STEM , CATALOG # 148284, LOT # 728810; BIOMET TIBIAL TRAY, CATALOG # 185203, LOT # 687230; BIOMET 360 TIB OFFSET ADAPTER, CATALOG # 185211, LOT # 430350. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE FEMORAL SCREW BACKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584372 VANGUARD SSK 360 FEMUR R 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 3573600

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R