BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5

    MDR report key: 19990755 · Received August 15, 2024

    Report

    Report Number
    1038671-2024-02855
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 15, 2024
    Report Date
    June 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): (B)(6) 02-022-45-4535 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T. (B)(6) 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. THE REPORTED 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 RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    EXPERIENCE REPORT USA. PATIENT ID: (B)(6). RELATED (B)(4). PATIENT COMPLAINED OF PAIN. IS THE REPORTED EVENT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS? YES . WHAT SIDE WAS EFFECTED? RIGHT . INITIAL IMPLANT DATE (INDEX SURGERY DATE) (B)(6) 2018. WAS THE PATIENT REVISED TO EXACTECH DEVICES? YES. PLEASE DESCRIBE BELOW: LOOSE FEMUR AND RECALLED POLY. IS THE REPORTED EVENT RELATED TO THE BREAKAGE OF A DEVICE? NO. DID THE REPORTED EVENT LEAD TO A SURGICAL DELAY/PROLONGATION? NO. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE, X-RAY AND EBI ATTACHED. PRODUCT NOT RETURNING: CHAIN OF COMMAND DUE TO RECALL. (B)(6) 02-020-11-0345 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5. UDI: (B)(4). 510K: K171045. PRO CODE: JWH. (B)(6) 02-022-35-4512 - TRULIANT TIB IMP PS INSERT SZ 4.5 12MM. *THE SERIAL NUMBER (B)(6) IS AFFECTED BY THE RECALL*. UDI: (B)(4). 510K: K171045. PRO CODE: JWH. CONCOMITANTS: (B)(6) 02-022-45-4535 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T. (B)(6) 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163385 TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention SEE H11.