BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL LOCKING BAR

    MDR report key: 8812555 · Received July 22, 2019

    Report

    Report Number
    0001825034-2019-03033
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    February 27, 2019
    Report Date
    December 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED IMPLANT SHOWS SIGNS OF WEAR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION WILL BE SENT TO THE COMPLAINANT. 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: VANGUARD AS TIBIAL BEARING, CATALOG # EP-189080, LOT # 835850. VANGUARD CR FEMORAL, CATALOG # 183030, LOT # 231010. BIOMET CC CRUCIATE TRAY, CATALOG # 141234, LOT # J3465523. COBALT G-HV BONE CEMENT 40G, CATALOG # 402283, LOT # 232350. COBALT G-HV BONE CEMENT 40G, CATALOG # 402283, LOT # 156410. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-03030, 0001825034-2019-03034, 0001825034-2019-03136.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION PROCEDURE DUE TO STIFFNESS APPROXIMATELY ONE YEAR POST-IMPLANTATION. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE YEAR LATER. DURING THE REVISION PROCEDURE, THE SURGEON NOTED THE TIBIA WAS ESSENTIALLY LOOSE AND EASILY REMOVED. THE IMPLANT HAD FAILED AT THE CEMENT IMPLANT INTERFACE. ALL THE IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607231 BIOMET MODULAR TIBIAL LOCKING BAR PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 759920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R