BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM POROUS COATED IM STEM WITH SCREW 14.5MM X 90MM

    MDR report key: 7860090 · Received September 10, 2018

    Report

    Report Number
    0001825034-2018-08752
    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
    JDI
    PMA / PMN Number
    PK123501
    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 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 YOKE CATALOG #: 150493 LOT #: 122870, 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 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
    700075 ORTHOPEDIC SALVAGE SYSTEM POROUS COATED IM STEM WITH SCREW 14.5MM X 90MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 080590

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R