BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS OPEN INTL FEM RT 70 70

    MDR report key: 7910201 · Received September 26, 2018

    Report

    Report Number
    0001825034-2018-09063
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    September 3, 2018
    Report Date
    May 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT CANNOT BE CONFIRMED SINCE MEDICAL OPERATIVE NOTES WERE NOT PROVIDED. VISUAL INSPECTION OF THE RETURNED FEMORAL SHOWS EXCESSIVE CEMENT RESIDUE WITH BLACK DEBRIS ON THEM BUT IT COULD NOT BE CONFIRMED TO BE METALLOSIS. THE FEMORAL COMPONENT SHOWED SIGNS OF WEAR ON THE SURFACE OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELEVANT DEVIATIONS OR ANOMALIES. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THE PLANNED REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL COMPONENT, A METALLOSIS-LIKE TISSUE WAS SHOWN (DARK COLORED SYNOVIAL TISSUE). THERE WERE SOME SCRATCHES ON THE FEMORAL COMPONENT AND, WHEN THE INSERT WAS REMOVED, THE SURFACE OF THE TIBIAL COMPONENT WAS WORN. THEREFORE A TOTAL KNEE REVISION WAS NEEDED. A SURGICAL DELAY OF FORTY FIVE (45) MINS WAS NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-09064, 0001825034-2018-09065. CONCOMITANT MEDICAL PRODUCTS: BIOMET CC CRUCIATE TRAY 79MM, ITEM# 141235, LOT# UNKNOWN. VNGD PS TIB BRG 12X79/83MM, ITEM# 183662, LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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, DURING THE PLANNED REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL COMPONENT, A METALLOSIS-LIKE TISSUE WAS SHOWN (DARK COLORED SYNOVIAL TISSUE). THERE WERE SOME SCRATCHES ON THE FEMORAL COMPONENT AND, WHEN THE INSERT WAS REMOVED, THE SURFACE OF THE TIBIAL COMPONENT WAS WORN. THEREFORE A TOTAL KNEE REVISION WAS NEEDED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751630 VNGD PS OPEN INTL FEM RT 70 70 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 788780

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R