BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 9MM

    MDR report key: 16480778 · Received March 3, 2023

    Report

    Report Number
    1038671-2023-00347
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 1, 2020
    Report Date
    June 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048387
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 2955632, 200-02-32 - THREE PEG PATELLA 32MM. 3003748, 204-04-44 - TRAPEZOID TIBIAL TRAY SZ 4F/4T. 1735336, 234-03-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4. CORRECTION/REMOVAL NUMBER: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    H10. MFR#S FOR THIS EVENT- 1038671-2024-01761. REPORT 2 OF 4, 1038671-2024-01762. REPORT 3 OF 4, 1038671-2024-01764. REPORT 4 OF 4. H11. ADDITIONAL MANUFACTURER NARRATIVE- ADDITIONAL INFORMATION ADDED. REPORT 1 OF 4. H3. INVESTIGATION RESULTS-THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE TIBIAL INSERT AND JOINT INSTABILITY. THE CAUSE AND EXTENT OF THE INSERT WEAR, AS WELL AS THE ALLEGED MISALIGNMENT, INSTABILITY, OSTEOLYSIS, AND LOOSENING CANNOT BE DETERMINED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. EXACTECH COMPLAINT HISTORY FROM 01/01/2008 ¿ 04/01/2024 WAS USED TO CALCULATE A COMPLAINT OCCURRENCE RATE FOR EACH ALLEGED FAILURE, RESPECTIVELY, OF <0.5%. THIS IS CONSIDERED ¿VERY LOW¿. THIS EVENT DOES NOT THIS DOES NOT APPEAR TO BE DESIGN-RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT AND RISK ASSESSMENT AND CONTROLS REPORT WAS CONDUCTED TO ENSURE THE RISKS WERE INCLUDED AND THE OCCURRENCES ARE BELOW THE THRESHOLD. CORRECTION - F6 & F8 SHOULD BE BLANK. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2014. THE PATIENT HAD A TIBIAL EXCHANGE ON (B)(6) 2018 DUE TO DEFECTIVE NATURE OF THE INSERT AND MALALIGNMENT. THE PATIENT HAD THE ENTIRE KNEE REDONE IN 2020 DUE TO EARLY FAILURE AND DEBRIS. DURING THE YEARS THE TIBIAL INSERTS WERE IN THE PATIENT'S BODY THE TIBIAL INSERTS EXCESSIVELY WORE AND SHED DEBRIS, RESULTING IN WORSE ALIGNMENT, BONE AND TISSUE DAMAGE, PAIN, EFFUSIONS, SWELLING, LOSS OF FUNCTION, THE NEED FOR THE INSERT EXCHANGE IN 2018 AND COMPLETE KNEE REPLACEMENT REVISION IN 2020 AND CONTINUING PAIN, SWELLING AND DYSFUNCTION. RELATED TO 1038671-2023-00346.

    Description of Event or Problem · 0

    REVISION OPERATIVE REPORT-PRE/POST OPERATIVE DIAGNOSIS: FAILED RIGHT TKA DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT FROM EARLY PATELLAR COMPONENT POLYETHYLENE WEAR FROM COMPONENT MALPOSITION AND DUE TO INSTABILITY. FINDINGS: GROSSLY ASYMMETRIC PATELLAR WEAR WITH PATELLAR MALTRACKING, TIGHT MEDIALLY AND VERY LOOSE LATERALLY THROUGHOUT ARC OF MOTION, GROSSLY LOOSE FEMORAL COMPONENT, GROSSLY LOOSE TIBIAL COMPONENT, OSTEOLYSIS UNDER TIBIAL AND FEMORAL COMPONENTS. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773020 PS TIBIAL INSERTS SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 204-24-09 10885862048387

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention