BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT

    MDR report key: 7287412 · Received February 21, 2018

    Report

    Report Number
    0001825034-2018-01214
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    January 19, 2018
    Report Date
    November 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 INSPECTION OF THE RETURNED DEVICE SHOWS THAT THE 3CM SEGMENT IS FRACTURED AT THE CONNECTOR AREA. THE RETURNED 7CM DIAPHYSEAL SEGMENT EXHIBITS WEAR AROUND THE CONNECTOR AREA. THE FRACTURED PIECE WAS STILL EMBEDDED WITHIN 7CM SEGMENT. THE SEM ANALYSIS REPORT FOR THE 3CM DIAPHYSEAL SEGMENT STATE THAT THE SEGMENT HAS NUMEROUS SCRATCHES, REMOVAL SAW CUTS & OTHER POST-FRACTURE DAMAGE. THE REMAINING VISIBLE FRACTURE ARTIFACTS SUGGEST THE FAILURE CAUSE WAS A FATIGUE FRACTURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN 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). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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 · 1

    CONCOMITANT MEDICAL PRODUCTS: OSS DIAPHYSEAL SEGMENT, CATALOG #: 150466, LOT #: 929150, OSS CEMENTED STEM, CATALOG #: 150376, LOT #: 788140, OSS STACKING ADAPTER, CATALOG #: 150483, LOT #: 525030, OSS FEMORAL SEGMENT, CATALOG #: 150354, LOT #: 619620, OSS FEMORAL BUSHING, CATALOG #: 150477, LOT #: 212210, OSS TIBIAL BEARING, CATALOG #: 150410, LOT #: 870650, OSS REINFORCED YOKE, CATALOG #: 150493, LOT #: 804750, OSS AXLE, CATALOG #: 150480, LOT #: 017430, OSS LOCKING PIN, CATALOG #: 150478, LOT #: 505790, OSS TIBIAL PLATE, CATALOG #: 161044, LOT #: 781440, OSS TIBIAL BUSHING, CATALOG #: 150476, LOT #: 185090. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS A FRACTURED DIAPHYSEAL SEGMENT. THE SURGERY TOOK OVER TWO HOURS TO REMOVE THE SEGMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128774 ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 858220

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R