BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 L FEM 75MM

    MDR report key: 9446745 · Received December 10, 2019

    Report

    Report Number
    0001825034-2019-05517
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    September 19, 2019
    Report Date
    March 26, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H1, H2, H3, H6, H10. D11 MEDICAL PRODUCT: BIOMET SPLINED KNEE STEM CATALOG 141878 LOT 039130. VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 408680. VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 723710. TIBIAL BEARING LOT 985950: BIOMET TIBIAL LOCKING BAR CATALOG 141205 LOT 884680. BIOMET 360 TIBIAL TRAY CATALOG 185206 LOT 184200. BIOMET SPLINED KNEE STEM CATALOG 148306 LOT 277800. BIOMET 60 OFFSET ADAPTER CATALOG 185211 LOT 497570. UNKNOWN COBALT BONE CEMENT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. CLINICAL NOTES FOUND THAT PATIENT HAD ONGOING KNEE PAINS; BONE SCAN SHOWS UPTAKE OVER FEMORAL COMPONENT SUGGESTING LOOSENING; DIAGNOSED WITH ASEPTIC FAILURE AND SEVERE BONE LOSS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET SPLINED KNEE STEM CATALOG 141658 LOT 039130. UNKNOWN FEMORAL COMPONENT LOT 3422678. VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 723710. VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 408680. TIBIAL BEARING LOT 985950. BIOMET TIBIAL LOCKING BAR CATALOG 141205 LOT 884680. BIOMET 360 TIBIAL TRAY CATALOG 185206 LOT 184200. BIOMET SPLINED KNEE STEM CATALOG 148306 LOT 277800. BIOMET 360 OFFSET ADAPTER CATALOG 185211 LOT 497570. UNKNOWN COBALT BONE CEMENT. THE PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT STILL REMAINS IMPLANTED. 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 THE PATIENT HAS BEEN INDICATED FOR A LEFT KNEE REVISION ARTHROPLASTY APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO ONGOING FEMORAL ASEPTIC FEMORAL LOOSENING WITH SEVERE BONE LOSS. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238061 VNGD SSK 360 L FEM 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 3422678

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R