BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 5, 9MM

    MDR report key: 16633082 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00531
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    February 14, 2018
    Report Date
    April 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048462
    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: 1111755 200-02-41 - THREE PEG PATELLA 41MM. 1931520 234-02-05 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 5, 2059194 204-04-55 - TRAPEZOID TIBIAL TRAY SZ 5F/5T. CORRECTION/REMOVAL NUMBER: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF LOOSENING AND PROSTHESIS WEAR. THE ASEPTIC (NON-INFECTED) FEMORAL AND TIBIAL LOOSENING WAS LIKELY THE RESULT OF INSUFFICIENT BOND BETWEEN THE COMPONENTS AND BONE. THE TIBIAL INSERT WEAR MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, F10 (REMOVE ERRONEOUS ENTRIES FROM INITIAL REPORT), G2, H6: CLINICAL CODES, COMPONENT CODE, TYPE OF INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION. 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 LEGAL NOTIFICATION, THE MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2011. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 SECONDARY TO COMPLETE POLYETHYLENE LINER WEAR AND DELAMINATION LINER WITH RESULTING SYNOVITIS, CYST FORMATION, OSTEOLYSIS OF THE FEMUR AND TIBIA, AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455235 PS TIBIAL INSERTS SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 204-25-09 10885862048462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.