BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID TIBIAL TRAY SZ 5F/5T

    MDR report key: 20532799 · Received October 25, 2024

    Report

    Report Number
    1038671-2024-04120
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    December 1, 2022
    Report Date
    November 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862047724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, FEMORAL LOOSENING, AND TIBIAL LOOSENING 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.

    Description of Event or Problem · 0

    LEGAL CASE - (B)(6). IT WAS REPORTED THAT A 65 YO PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 8 YEARS POST THE INITIAL PROCEDURE. THE PATIENT HAD BEEN SEEN BY THE SURGEON IN AN OUTPATIENT CLINIC. THE PATIENT HAD CONSTANT PAIN AND INSTABILITY THAT FAILED CONSERVATIVE TREATMENT. THE PRE-PROCEDURE DIAGNOSIS INDICATED ASEPTIC LOOSENING OF COMPONENTS, ARTHROPLASTY WEAR OF THE POLYETHYLENE LINER. THE POLYETHYLENE WAS REMOVED WITH AN OSTEOTOME WITHOUT DIFFICULTY. THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND WAS DIS-IMPACTED WITHOUT DIFFICULTY. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND WAS DIS-IMPACTED OFF THE TIBIAL PLATEAU WITHOUT DIFFICULTY AND THERE WAS MINIMAL BONE LOSS. THE TIBIAL STEM AND BONE CEMENT WERE REMOVED. COMPETITOR¿S DEVICES WERE RE-IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION WITH STABLE VITAL SIGNS HAVING TOLERATED THE PROCEDURE WELL WITHOUT APPARENT COMPLICATIONS. REVISED TO STRYKER. SERIAL #: (B)(6), CATEGORY #: 208-25-13 - CC TIBIAL INSERT SZ 5, 13MM, 510K: K954208; JWH; Z-0019-2022. CONCOMITANTS: SERIAL #: (B)(6), CATEGORY #: 204-04-55 - TRAPEZOID TIBIAL TRAY SZ 5F/5T, SERIAL #: (B)(6), CATEGORY #: 200-02-35 - THREE PEG PATELLA 35MM, SERIAL #: (B)(6), CATEGORY #: 204-34-08 - FLUTED STEM EXTENSION 80L X 14 MM, SERIAL #: (B)(6), CATEGORY #: 204-38-12 - STEM EXTENSION W/SLOT 120L X18 MM, SERIAL #: (B)(6), CATEGORY #: 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE, SERIAL #: (B)(6), CATEGORY #: 208-01-05 - CC FEMORAL SZ 5, SERIAL #: (B)(6), CATEGORY #: 1510-S - CEMEX SYSTEM FAST 70 GM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889778 TRAPEZOID TIBIAL TRAY SZ 5F/5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862047724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H UNK.