BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE COMPONENTS

    MDR report key: 15675277 · Received October 26, 2022

    Report

    Report Number
    1038671-2022-01353
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 19, 2022
    Report Date
    November 9, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. CONCOMITANT MEDICAL PRODUCTS: 01-040-01-0254 - LOGICAL G-SERIES CUP SHELL 3 HOLE SZ 54C, 82340; 01-041-01-0236 - LOGICAL XLPE LINER NEUTRAL SZ 36C, 85D7A-2; 01-041-50-6525 - LOGICAL CUP BONE SCREW 25MM, 83FBD, 861AC-1; 01-045-00-3600 - FEMORAL HEAD CERAMIC 36MM (M, +0MM), 84C5E-1.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. ADDITIONAL INFORMATION: PATIENT DID NOT HAVE A FALL AND THE ONLY COMORBIDITY I KNOW OF WAS BEING OVERWEIGHT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 71 YO FEMALE THAT HAD A TOTAL HIP REPLACEMENT ON (B)(6) 2022, SHOWED UP TO HER TWO WEEK APPOINTMENT UNABLE TO BEAR WEIGHT AND IN A WHEEL CHAIR. IT IS STATED THAT THE PATIENT DID NOT HAVE A TRAUMA AND IS OVERWEIGHT. THE SURGEON GOT AN X-RAY AND NOTICED A NONCOMPLETE FRACTURE OF HER CALCAR. THE SURGEON GOT A CT AND CAN SEE THE FRACTURE CLEARLY. THE MEDICAL PLAN IS TO LIMIT WEIGHT BEARING FOR 8 WEEKS HOPING FOR FRACTURE TO HEAL AND STEM TO STABILIZE. NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599623 KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other SEE H10