BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 9MM

    MDR report key: 15494564 · Received September 27, 2022

    Report

    Report Number
    1038671-2022-01175
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    September 2, 2022
    Report Date
    October 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304254
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION FOR PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER IT IS MOST LIKELY RELATED TO PATIENT CONDITION. CONCOMITANT DEVICE(S): 02-020-12-0330, 6481777 - TRULIANT PS POR FEM PS POR RIGHT SZ 3. 02-022-55-3030, 6649304 - TRULIANT POR TIB TRAY SIZE 3F/3T. 200-02-35, 6737224 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    1038671-2024-04113 H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING. THE REPORTED PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING COULD NOT BE CONFIRMED. 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, RADIOGRAPHS AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. ADDITIONALLY, THIS DEVICE WAS PACKAGED AFTER INITIATION OF THE RECALL AND WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 52 Y/O MALE PATIENT WAS REVISED DUE TO PAIN. PATIENT CAME IN WITH PAINFUL KNEE "CLEAN TO DO TO LINER RECALL". SURGEON REVISED A POROUS KNEE TO A COMPETITORS KNEE REPLACEMENT SYSTEM. PATIENT OUTCOME IS UNKNOWN, REPRESENTATIVE WAS NOT ALLOWED TO BE PRESENT FOR THE SURGERY. DEVICES ARE NOT RETURNING; IMPLANTS WERE GIVEN TO A LAWYER. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539384 TRULIANT TIB IMP PS INSERT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-35-3009 UNK 10885862304254

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention SEE H10.