BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM

    MDR report key: 16485668 · Received March 6, 2023

    Report

    Report Number
    1038671-2023-00349
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    October 1, 2019
    Report Date
    January 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173577
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: 4882023, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T; 4886792, 02-012-50-2011 - LOGIC FIT/RBK AUGMENT 1/2 BLOCK SZ 2, 5MM; 4886805, 02-012-50-2011 - LOGIC FIT/RBK AUGMENT 1/2 BLOCK SZ 2, 5MM; 5180835, 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM; 5367594, 204-70-00 - TIBIAL STEM EXT. SCREW. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6. THE FOLLOWING SECTIONS WERE CORRECTED: D1/D2A/D2B, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. 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 VIA LEGAL NOTIFICATION, THAT PATIENT'S SECOND OPTETRAK LOGIC PSC TIBIAL INSERT IMPLANTED IN PLAINTIFF ON (B)(6) 2018 FAILED, CAUSING PLAINTIFF KNEE PAIN AND DIFFICULTY WALKING. DUE TO THE PAIN, DISCOMFORT, AND DIFFICULTY WALKING RELATED TO THE SECOND OPTETRAK LOGIC PSC TIBIAL INSERT IMPLANTED INTO PLAINTIFF, PLAINTIFF WAS FORCED TO UNDERGO A SECOND REVISION SURGERY ON (B)(6) 2019, APPROXIMATELY 1 YEAR 5 MONTHS POST REVISION PROCEDURE, AT WHICH TIME SHE WAS IMPLANTED WITH A THIRD TIBIAL INSERT. AGAIN, TELLINGLY, DURING THE SECOND REVISION PROCEDURE, PLAINTIFF¿S SURGEON NOTED THERE WAS ¿LOOSENING OF THE TIBIAL COMPONENT¿ THAT REQUIRED THE SECOND REVISION SURGERY. THE INSERT IMPLANTED INTO PLAINTIFF¿S KNEE ON (B)(6) 2019 IS AN EXACTECH TRULIANT PSC TIBIAL INSERT¿AN INSERT THAT HAS SINCE BEEN RECALLED. AT THIS TIME, IT IS UNKNOWN WHETHER THE TRULIANT PSC TIBIAL INSERT IMPLANTED INTO PLAINTIFF HAS FAILED LIKE THE PREVIOUS TWO OPTETRAK LOGIC PSC TIBIAL INSERTS IMPLANTED INTO PLAINTIFF, BUT PLAINTIFF CONTINUES TO SUFFER PAIN, DISCOMFORT, AND DIFFICULTY WALKING, ALL RELATING TO THE MULTIPLE REVISION SURGERIES SHE HAS UNDERGONE DUE TO THE FAILURES OF THE TWO OPTETRAK LOGIC PSC TIBIAL INSERTS IMPLANTED INTO HER RIGHT KNEE. TO THIS DAY, PLAINTIFF CONTINUES TO EXPERIENCE PAIN, DISCOMFORT, DIFFICULTY WALKING, AND LIMITED RANGE OF MOTION AS A RESULT OF THE INITIAL IMPLANT OF THE DEVICE AS WELL AS THE SUBSEQUENT REVISION SURGERIES. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497168 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM UNK 10885862173577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention