BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM BOWED IM STEM WITH SCREW 14.5MM X 225MM

    MDR report key: 8213572 · Received January 3, 2019

    Report

    Report Number
    0001825034-2019-00039
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    December 7, 2018
    Report Date
    June 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI # - (B)(4). CONCOMITANT MEDICAL PRODUCTS- ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BEARING 12MM CATALOG #: 150410 LOT #: 176690, ORTHOPEDIC SALVAGE SYSTEM RS AXLE CATALOG #: 161035 LOT #: 127650, ORTHOPEDIC SALVAGE SYSTEM 5CM DIAPHYSEAL SEGMENT CATALOG #: 150465 LOT #: 222890, ORTHOPEDIC SALVAGE SYSTEM RS 7CM MODULAR SEGMENTED FEMORAL COMPONENT RIGHT CATALOG #: 161011 LOT #: 460970, ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS CATALOG #: 161034 LOT #: 549070, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE LOCKING PIN CATALOG #: 150510 LOT #: 423510, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING CATALOG #: 150476 LOT #: 443300, ORTHOPEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 67MM CATALOG #: 150421 LOT #: 523710, ORTHOPEDIC SALVAGE SYSTEM TIBIAL AUGMENT BLOCK 10MM X 63/67MM CATALOG #: 150426 LOT #: 225600 , ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOLK CATALOG #: 150493 LOT #: 017000, ORTHOPEDIC SALVAGE SYSTEM LOCKING SCREW CATALOG #: 150475 LOT #: 921650, ORTHOPEDIC SALVAGE SYSTEM CEMENTED PROXIMAL TIBIAL STEM 11MM X 150MM CATALOG #: 150445 LOT #: 751190.

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED. REPORTED FRACTURE EVENT WAS CONFIRMED VIA OPERATIVE NOTES AND REVIEW OF PROVIDED RADIOGRAPHS. VIEW OF THE RIGHT FEMORAL STEM DEMONSTRATED FRACTURE OF THE STEM AND THE ADJACENT FEMUR WITH MILD DISPLACEMENT. THE SURGEON NOTED DURING THE REVISION THAT THE MEDIAL SEGMENT HAD FRACTURED, THERE WERE NO SIGNS OF INFECTION, AND NO COMPLICATIONS WERE NOTED DURING THE REVISION. DEVICE HISTORY RECORD (DHR) REVIEW IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. ROOT CAUSE WAS UNABLE TO 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN; ORTHOPEDIC SALVAGE SYSTEM BEARING CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE; SYSTEM FEMORAL COMPONENT CATALOG #: NI LOT #: NI. IT IS INDICATED BY THE COMPLAINANT THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS NO RESPONSE HAS BEEN RECEIVED REGARDING THE DEVICE'S WHEREABOUTS. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE BREAKAGE OF THE FEMORAL STEM FOLLOWING KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4778 ORTHOPEDIC SALVAGE SYSTEM BOWED IM STEM WITH SCREW 14.5MM X 225MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 323590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R