BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++

    MDR report key: 15969400 · Received December 13, 2022

    Report

    Report Number
    1038671-2022-01594
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 8, 2022
    Report Date
    July 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041210
    PMA / PMN Number
    K082022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 00-T193-119-90 - OSCILLATOR BLADE M-CLASS 19/13X 1.19X90MM 547475. 200-04-22 - CEMENT TYPE FINNED TIVIAL TRAY 2F/2T 3917071. 230-03-02 - CR CEMENT TYPE AK FEMORAL COMPONENTS R-2 3931731. A10007 - GPS DISPOSABLE KIT 1016015004. TN190-119-05 - OSCILLATING BLADE M-CLASS 19X1.19X105 644015. CORRECTION/REMOVAL NUMBER: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY DUE TO PROGRESSIVE PROSTHESIS WEAR OVER 7 YEARS OF IMPLANTATION SECONDARY TO MECHANICAL OVERLOAD ON THE POSTERIOR MEDIAL EDGE OF THE TIBIAL INSERT LEADING TO FULL THICKNESS POLYETHYLENE WEAR AND METALLIC WEAR OF THE TIBIAL TRAY. CONTRIBUTIONS FROM OVERALL SLOPE OF THE INSERT AND TIBIAL TRAY, ROTATIONAL MALALIGNMENT AND/OR SOFT TISSUE INSTABILITY MAY HAVE ALLOWED FOR EXCESSIVE POSTERIOR CONTACT LEADING TO WEAR OF THE POLYETHYLENE INSERT. HOWEVER, THE CONTRIBUTIONS OF INDIVIDUAL FACTORS OR A COMBINATION OF THE AFOREMENTIONED FACTORS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY DUE TO PROGRESSIVE PROSTHESIS WEAR OVER 7 YEARS OF IMPLANTATION SECONDARY TO MECHANICAL OVERLOAD ON THE POSTERIOR MEDIAL EDGE OF THE TIBIAL INSERT LEADING TO FULL THICKNESS POLYETHYLENE WEAR AND METALLIC WEAR OF THE TIBIAL TRAY AND/OR FEMORAL COMPONENT. CONTRIBUTIONS FROM OVERALL SLOPE OF THE INSERT AND TIBIAL TRAY, ROTATIONAL MALALIGNMENT AND/OR SOFT TISSUE INSTABILITY MAY HAVE ALLOWED FOR EXCESSIVE POSTERIOR CONTACT LEADING TO WEAR AND POSSIBLE FRACTURE OF THE POLYETHYLENE INSERT. HOWEVER, THE CONTRIBUTIONS OF INDIVIDUAL FACTORS OR A COMBINATION OF THE AFOREMENTIONED FACTORS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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, THIS PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2015. THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN AND THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT. THE PATIENT WAS REVISED ON (B)(6) 2022. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT, AS WELL AS METALLOSIS. THE SURGEON REMOVED PARTS AND PIECES OF POLYETHYLENE PARTICLES AND PROLIFERATIVE TISSUES WERE RESECTED BY THE SURGEON APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129966 CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++ PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 200-72-09 10885862041210

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention SEE H10