BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC PSC TIB INS SZ 4 17MM

    MDR report key: 18711061 · Received February 15, 2024

    Report

    Report Number
    1038671-2024-00231
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    May 19, 2023
    Report Date
    December 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862248145
    PMA / PMN Number
    K132161
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 4996482, 02-012-60-1612 - TRU STEM EXT 16MM X 120MM 5107754, 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 4896527, 02-022-45-4050 - TRULIANT TIB FIT TRAY CEM SZ 4F / 5T 4954181, 200-02-38 - THREE PEG PATELLA 38MM 5022852, 204-70-00 - TIBIAL STEM EXT. SCREW PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, A FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, WHICH LED TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE, AND/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. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT WAS INITIALLY IMPLANTED WITH A RIGHT TOTAL KNEE ARTHROPLASTY (B)(6) 2017 AND THEN APPROXIMATELY 5 YEARS 6 MONTHS, LATER WAS SURGICALLY REVISION ON (B)(6) 2023. REVISION OPERATIVE REPORT OF (B)(6) 2023, POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE POLYETHYLENE AND FEMORAL COMPONENT DUE TO PREMATURE POLYETHYLENE WEAR AND OSTEOLYSIS DUE TO POLY RECALL. PATIENT REVISED TO EXACTECH DEVICES. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION, THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. THERE IS NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496013 LOGIC PSC TIB INS SZ 4 17MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862248145

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention SEE H10