BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 18637108 · Received February 3, 2024

    Report

    Report Number
    1038671-2024-00151
    Event Type
    Injury
    Date Received
    February 3, 2024
    Date of Event
    June 16, 2023
    Report Date
    January 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 02-010-01-0210 - LOGIC FEMORAL PS CEM LEFT SZ 1 5843123. 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T: 5717918. 200-02-29 - THREE PEG PATELLA 29MM: 6982502. A10012 - GPS IMPLANT KIT V2: 05001221048.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8. THE FOLLOWING SECTIONS WERE CORRECTED: D4: CATALOG NUMBER, SERIAL NUMBER, EXPIRATION DATE, UDI UNKNOWN. G4:510K UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED. H4: MANUFACTURE DATE UNKNOWN. A REVIEW OF THE STERILE CERTIFICATES FOR THE TIBIAL INSERT, FEMORAL COMPONENT, PATELLA, AND TIBIAL TRAY WAS PERFORMED. ALL STERILE LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. 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.

    Additional Manufacturer Narrative · 0

    (D10) REPORTED CONCOMITANT DEVICES: 02-012-44-1009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM: (B)(6), 02-010-01-0210 - LOGIC FEMORAL PS CEM LEFT SZ 1 (B)(6), 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T: (B)(6), 200-02-29 - THREE PEG PATELLA 29MM: (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5, D1, D4 - REMOVE ALL, D10, G1 - CONTACT FIST/LAST NAME, EMAIL, G4 - REMOVE. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. A REVIEW OF COMPLAINT HISTORY WAS UNABLE TO BE PERFORMED AS THE RELEVANT DEVICE AND EVENT INFORMATION WAS UNKNOWN. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM AN UNDERLYING PATIENT CONDITION. 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 EGPS LEVEL 1 CLINICAL STUDY, THE 79 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021 AND PRESENTED WITH INFECTION 2 YEAR(S) AND 4 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2024. ON (B)(6) 2023 - PATIENT REPORTED KNEE PAIN, ARTHROCENTESIS PERFORMED. (B)(6) 2023 - LABORATORY RESULTS POSITIVE AND PTR REPLACEMENT DECIDED. (B)(6) 2023 - PTR REPLACEMENT PERFORMED. 01/10/2024 - CONTROL VISIT WITH OK RESULT. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION TAKEN WAS 07/31/2023, PTR REPLACEMENT IS MADE. THE OUTCOME IS REPORTED AS CONTINUING. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    APPROXIMATELY 2 YEAR(S), 4 MONTH(S) AND 10 DAY(S) POST-OPERATIVE OF A LEFT TKA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED INFECTION - KNEE PAIN, ARTHROCENTESIS PERFORMED WITH LABORATORY RESULTS POSITIVE AND PTR REPLACEMENT DECIDED AND PERFORMED. CONTROL VISIT WITH OK RESULT. THE PTR REPLACEMENT WAS PERFORMED FOR THIS PATIENT AND THE OUTCOME OF THIS EVENT IS NOW CONSIDER RESOLVED BY A FOLLOW UP VISIT 7 MONTHS FOLLOWING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557389 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female