BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE COMPONENT

    MDR report key: 18784346 · Received February 26, 2024

    Report

    Report Number
    1038671-2024-00318
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    December 1, 2023
    Report Date
    April 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THE INITIAL SURGERY RESULTS WERE FOUND THROUGH RESEARCH BY ENGINEERING. CONCOMITANTS -PRODUCT INFORMATION: LEFT KNEE: 6377163 02-020-11-0230 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3; 6408804 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T; 6504985 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT RIGHT KNEE: 5952594 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT; 6433934 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3; 6474265 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T. H6. INVESTIGATION RESULTS - THERE IS NO SPECIFIC TRULIANT DEVICE INFORMATION PROVIDED OR THE KNEE AFFECTED. THE CAUSE OF THE PATIENT'S CONDITION AND PLANNED REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H10. PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    H10: D10: ADDITIONAL INFORMATION: THE INITIAL EBI SURGERY RESULTS WERE FOUND THROUGH RESEARCH BY ENGINEERING. CONCOMITANTS -PRODUCT INFORMATION: LEFT KNEE: 6377163 02-020-11-0230 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3; 6408804 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T; 6504985 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT RIGHT KNEE: 5952594 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT; 6433934 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3; 6474265 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F/2T. H6. INVESTIGATION RESULTS: THERE IS NO SPECIFIC TRULIANT DEVICE INFORMATION PROVIDED OR THE KNEE AFFECTED. THE CAUSE OF THE PATIENT'S CONDITION AND PLANNED REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL TOTAL KNEE ARTHROPLASTY. THE IMPLANT DATE WAS NOT PROVIDED. THE PLANNED REVISION HAS NOT BEEN REPORTED AS OF THIS DATE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION OR DEVICE INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118848 KNEE COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10| SEE H10