BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID TIBIAL TRAY SZ 3F/3T

    MDR report key: 20054564 · Received August 23, 2024

    Report

    Report Number
    1038671-2024-03056
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    February 19, 2024
    Report Date
    November 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862047663
    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

    CONCOMITANTS: 1366942 244-23-11 - OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 11MM 1394064 244-03-03 - OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, RIGHT 0801199 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. 0740467 204-70-00 - TIBIAL STEM EXT. SCREW 1408388 200-02-35 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    REPORT NUMBERS: 1038671-2024-01115, 1038671-2024-03043, 1038671-2024-03044. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4 D10 CONCOMITANT DEVICES: (B)(6) 204-04-33 - TRAPEZOID TIBIAL TRAY SZ 3F/3T (B)(6) 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, BONE FRACTURE, TIBIAL LOOSENING, AND FAILURE OF THE CEMENT TO SECURE TO FEMORAL COMPONENT, LEADING TO FEMORAL LOOSENING. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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

    LEGAL CASE ¿ USA PATIENT ID: (B)(6) + LEFT KNEE (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 181 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, POLYETHYLENE WEAR OF TIBIAL INSERT AND PATELLA, FEMORAL AND TIBIAL LOOSENING; TIBIAL BONE FRACTURE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618469 TRAPEZOID TIBIAL TRAY SZ 3F/3T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862047663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11| SEE H11