BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM

    MDR report key: 16454100 · Received February 28, 2023

    Report

    Report Number
    1038671-2023-00267
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    March 14, 2022
    Report Date
    May 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173539
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITTANTS: 4891046 02-012-41-2525 - LOGIC TIBIA TRAPTRAY CEM SZ 2.5F/2.5T. 6001228 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5. 6038791 200-02-35 - THREE PEG PATELLA 35MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. CORRECTED FIELDS: B1, B2, B3, D6B, G3, H6; CLINICAL CODES, MEDICAL PROBLEM CODE, COMPONENT CODE ADDITIONAL INFORMATION: A2, A3, B5, D10, G, G2, H6 INVESTIGATION CODES D10: SERIAL #: (B)(6), CATEGORY #: 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5, SERIAL #: (B)(6), CATEGORY #: 02-012-41-2525 - LOGIC TIBIA TRAPTRAY CEM SZ 2.5F/2.5T, SERIAL #: (B)(6), CATEGORY #: 200-02-35 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, E. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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 A LEGAL NOTIFICATION, THAT A PATIENT, INITIAL LEFT TOTAL KNEE REPLACEMENT, IMPLANTED WITH A TRULIANT DEVICE ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 6 MONTHS POST THE INITIAL PROCEDURE, FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. THE PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 31 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY TO ADDRESS DISCOMFORT, SWELLING AND SYNOVIAL EFFUSION. A POST OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO POLYETHYLENE WEAR. INTRAOPERATIVELY THE SURGEON OBSERVED HYPERTROPHIC SYNOVIAL REACTION AND SYNOVITIS. THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED WITH NO EVIDENCE OF LOOSENING. THE POLYETHYLENE TIBIAL COMPONENT WAS THEN REMOVED AND NOTED TO HAVE SIGNIFICANT WEAR DELAMINATION OF THE MEDIAL ASPECT. THE PATELLA COMPONENT WAS NOTED AS NOT SIGNIFICANTLY WORN AND IN GOOD SHAPE. THE TIBIAL INSERT WAS REPLACED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409530 LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM UNK 10885862173539

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention| H SEE H10| SEE H11