BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 10MM

    MDR report key: 19273294 · Received May 8, 2024

    Report

    Report Number
    1038671-2024-01130
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    July 27, 2023
    Report Date
    November 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 9000221112 A10012 - GPS IMPLANT KIT V2. 6787885 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T. 6870024 200-02-38 - THREE PEG PATELLA 38MM. 7026376 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5. M001472 02-022-44-3011 - TRULIANT TIB IMP PSC INSERT SZ 3, 11MM. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D4: CORRECTED D10: CONCOMITANT DEVICES: 9000221112 (B)(6) - GPS IMPLANT KIT V2 (B)(6) 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T (B)(6) 200-02-38 - THREE PEG PATELLA 38MM (B)(6) 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5 G3: CORRECTED H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 19 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PREMATURE AND UNNECESSARY REVISION SURGERY, TISSUE LOSS AND BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140670 TRULIANT TIB IMP PS INSERT SZ 3 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10| SEE H11