BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM RESURFACING FEMORAL COMPONENT 3CM LEFT

    MDR report key: 8492328 · Received April 8, 2019

    Report

    Report Number
    0001825034-2019-01619
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 20, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS INFECTION APPROXIMATELY SIX (6) MONTHS POST-OPERATIVELY THAT DEVELOPED AFTER A FALL. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC CEMENT MOLDS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES - ORTHOPEDIC SALVAGE SYSTEM NON-MODULAR LONG TIBIAL BASEPLATE 75MM, CATALOG #: 161044, LOT #: 542520; ORTHOPEDIC SALVAGE SYSTEM TIBIAL BEARING 12MM, CATALOG #: 150410, LOT #: 367920; ORTHOPEDIC SALVAGE SYSTEM BOWED IM STEM WITH SCREW 14.5MM X 150MM, CATALOG #: 150393, LOT #: 015190; ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN, CATALOG #: 150478, LOT #: 229050; ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING, CATALOG #: 150476, LOT #: 344080; ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHINGS SET, CATALOG #: 150477, LOT #: 206400; ORTHOPEDIC SALVAGE SYSTEM AXLE, CATALOG #: 150480, LOT #: 262920; ORTHOPEDIC SALVAGE SYSTEM YOKE, CATALOG #: 150493, LOT #: 900460; REFOBACIN BONE CEMENT R 1 X 40, CATALOG #: 110034355, LOT #: 730BAD2003. THE COMPLAINANT HAS NOT YET INDICATED WHETHER 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT. PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2019-01620, 0001825034-2019-01621, 0001825034-2019-01622, 0001825034-2019-01623, 0001825034-2019-01624, 0001825034-2019-01625, 0001825034-2019-01626, 0001825034-2019-01627. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS INFECTION APPROXIMATELY SIX (6) MONTHS POST-OPERATIVELY. ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC CEMENT MOLDS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287053 ORTHOPEDIC SALVAGE SYSTEM RESURFACING FEMORAL COMPONENT 3CM LEFT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 956910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R