BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 22080506 · Received May 23, 2025

    Report

    Report Number
    1038671-2025-02135
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    January 25, 2021
    Report Date
    August 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE JOINT EFFUSION AND PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. D1: CORRECTED. H6: CORRECTED INVESTIGATION CLINICAL CODES. H10: 1038671-2025-02133, 1038671-2025-02132, 1038671-2025-02131, 1038671-2025-02136.

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 02-010-06-0230 - TRU CC FEMORAL SIZE 3 LEFT: (B)(6). 02-022-44-3013 - TRULIANT TIB IMP PSC INSERT SZ 3, 13MM: (B)(6). 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T: (B)(6). 02-012-61-2000 - TRU OFFSET STEM EXT COUPLER, 2MM: (B)(6). 02-012-61-6000 - TRU OFFSET STEM EXT COUPLER, 6MM: (B)(6). 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT: (B)(6). 02-012-66-2000 - METAPHYSEAL TIBIAL CONE, ML32MM: (B)(6). 02-012-60-1680 - TRU STEM EXT 16MM X 80MM: (B)(6). 02-012-50-2014 - TRU TIB AUG 1/2 RL SZ 2, 10MM: (B)(6). 02-012-60-1280 - TRU STEM EXT 12MM X 80MM: (B)(6). 204-70-00 - TIBIAL STEM EXT. SCREW: (B)(6). 02-012-50-2013 - TRU TIB AUG 1/2 RM SZ 2, 10MM: (B)(6). 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM: 6(B)(6). 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM: (B)(6). 208-07-03 - CC POSTERIOR FEM AUGMENT SZ 3, 5MM: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE, FOLLOWED BY TWO JOINT ASPIRATIONS, ONE INJECTION, AND TWO KNEE REVISIONS. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING RESIDUAL FLUID AT THE WOUND SITE. AS A RESULT, APPROXIMATELY 3 MONTHS AFTER PREVIOUS REVISION, THE PATIENT UNDERWENT A JOINT ASPIRATION OF FLUID AND CORTISONE INJECTION OF THE LEFT KNEE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320952 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention SEE H11.