BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD ARTHRO NL 1CM DIASL CNCTR

    MDR report key: 8863752 · Received August 6, 2019

    Report

    Report Number
    0001825034-2019-03444
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 9, 2019
    Report Date
    February 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K042409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 IDENTIFIED FRACTURING, AND NOT ALL PIECES WERE RETURNED. FURTHER ANALYSIS OF THE DEVICE SHOWED THAT IT FRACTURED DUE TO FATIGUE. MEDICAL RECORDS WERE ALSO PROVIDED AND CONFIRMED A REVISION OCCURRED ON THE PATIENT DUE TO FRACTURING OF THE DEVICE. OFFICE NOTES STATED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY UNTIL THEY DEVELOPED PATHOLOGICAL PAIN IN THE RIGHT KNEE, CAUSING THEM TO BEAR ALL OF THEIR WEIGHT ON THE LEFT EXTREMITY. PATIENT PRESENTED TO THE ER WHERE X-RAYS SHOWED A FRACTURED JUNCTION/CONNECTOR PIECE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE PATIENT WAS OBESE WITH MEDIUM ACTIVITY LEVEL, WHICH COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE EVENT. HOWEVER, A ROOT CAUSE CANNOT 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

    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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES - MODULAR ARTHRODESIS NAIL DIAPHYSEAL CONNECTOR 1CM, CATALOG #: CP260605, LOT #: 236860; MODULAR ARTHRODESIS NAIL DIAPHYSEAL CONNECTOR 1CM, CATALOG #: CP260605, LOT #: 161950; ORTHOPEDIC SALVAGE SYSTEM INTRAMEDULLARY STEM 21.5MM X 150MM, CATALOG #: 150400, LOT #: 360910; ORTHOPEDIC SALVAGE SYSTEM INTRAMEDULLARY STEM 18.5MM X 225MM, CATALOG #: 150405, LOT #: 898500; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL COMPONENT, CATALOG #: NI, LOT #: NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL COMPONENT, CATALOG #: NI LOT #: NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING, CATALOG #: NI, LOT #: NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHING, CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM YOKE CATALOG #: NI, LOT #: NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM AXLE, CATALOG #: NI, LOT #: NI; UNKNOWN ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN, CATALOG #: NI, LOT #: NI. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION APPROXIMATELY ONE (1) YEAR AND SIX (6) MONTHS POST-OPERATIVELY TO ADDRESS IMPLANT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661411 MOD ARTHRO NL 1CM DIASL CNCTR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 236860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE