BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM YOKE

    MDR report key: 7860043 · Received September 10, 2018

    Report

    Report Number
    0001825034-2018-08748
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    September 2, 2015
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. THE REPORTED ISSUES ARE RELATED TO THE PROCEDURE AND NOT ABNORMAL TO THE PROCEDURE WITH NO FAILURE DETECTED WITH THE DEVICES. 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 DEVICES ¿ ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHINGS 2PK, CATALOG #: 150477, LOT #: 250110; ORTHOPEDIC SALVAGE SYSTEM POROUS COATED STRAIGHT IM, STEM 16.5MM X 150MM, CATALOG #: 150451, LOT #: 785670; BIOMET SUTURE BUTTON SINGLE ¼ INCH PEG WITH WIRE 37MM X 10MM, CATALOG #: 11-150863, LOT #: 156460; ORTHOPEDIC SALVAGE SYSTEM RESURFACING POROUS COATED FEMORAL COMPONENT 5CM RIGHT, CATALOG #: 150352, LOT #: 121720; ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN, CATALOG #: 150478, LOT #: 233570; ORTHOPEDIC SALVAGE SYSTEM 71MM MODULAR TIBIAL BASE WITH PLUG, CATALOG #: 150422, LOT #: 140340; ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING, CATALOG #: 150476, LOT #: 180710; ORTHOPEDIC SALVAGE SYSTEM POROUS COATED IM STEM WITH SCREW 14.5MM X 90MM, ORTHOPEDIC SALVAGE SYSTEM 22MM TIBIAL BEARING, CATALOG #: 150415, LOT #: 982670; ORTHOPEDIC SALVAGE SYSTEM AXLE, CATALOG #: 150480, LOT #: 407180; VANGUARD SERIES A STANDARD PATELLA 37MM X 10MM, CATALOG #: 184768, LOT #: 533400. IT IS INDICATED BY THE COMPLAINANT THAT THE DEVICES WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES CURRENTLY REMAIN IMPLANTED. 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 EVENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2018-08744, 0001825034-2018-08745, 0001825034-2018-08746, 0001825034-2018-08747, 0001825034-2018-08748, 0001825034-2018-08749, 0001825034-2018-08750, 0001825034-2018-08751, 0001825034-2018-08752, 0001825034-2018-08753, 0001825034-2018-08754, 0001825034-2018-08755. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT DEVELOPED BILATERAL PULMONARY EMBOLI ONE DAY FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS MONITORED AT THE HOSPITAL AND WAS GIVEN XARELTO AND BED REST FOR TREATMENT. THE PATIENT WAS DISCHARGED SIX DAYS FOLLOWING THE PROCEDURE AFTER THE SURGEON FELT HIS CONDITION WAS STABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701413 ORTHOPEDIC SALVAGE SYSTEM YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 122870

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R