BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 41MM

    MDR report key: 21307210 · Received February 4, 2025

    Report

    Report Number
    1038671-2025-00646
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    April 3, 2023
    Report Date
    February 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039620
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. D10 CONCOMITANTS: 2144076 02-012-47-5009 - LOGIC CR TIB INSERT STD, SZ 5, 9MM; 4300108 02-010-03-0250 - LOGIC CR FEMORAL CEM, LEFT; 4139909 204-70-00 - TIBIAL STEM EXT. SCREW; 4161516 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T; 4331326 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM; AA9835 1400-AG - CEMEX GENTO LOW VISCOSITY 40G KIT.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 7 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE. THE PATIENT HAS SUFFERED DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT, SWELLING, GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133693 THREE PEG PATELLA 41MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. THREE PEG PATELLA 41MM 10885862039620

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H SEE H11.