BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 18717003 · Received February 15, 2024

    Report

    Report Number
    1038671-2024-00236
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    March 25, 2019
    Report Date
    July 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 02-020-13-0345 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 4.5: 5225138 02-022-45-4555 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/5.5T: 5144043 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: 5410208.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR SURGICAL PROCEDURE. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL RISK, AS OUTLINED IN THE IFU. 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

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 62 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018 AND PRESENTED WITH INFECTION, 0 YEAR(S) AND 4 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2019. (B)(6) 2018: PATIENT REPORTS MILD SWELLING, MODERATE PAIN, AND NO DRAINAGE. (B)(6) 2019: MODERATE SWELLING, PAIN DECREASED. (B)(6) 2019: PATIENT REPORTS MODERATE SWELLING, DECREASED PAIN - ARTHROCENTESIS; SYNOVASURE REVEALED + STAPHYLOCOCCUS PANEL. REVISION SCHEDULED (B)(6) 2019. REVISION: DEBRIDEMENT, ROH, INSERT SPACER W DRUG ELUTING STENT. REFER TO ID. THIS CASE IS RELATED TO (B)(4). THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION TAKEN ON (B)(6) 2019 WAS REVISION. THE OUTCOME IS REPORTED AS CONTINUING. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733895 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male SEE H10