BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4, 15MM

    MDR report key: 15324836 · Received August 30, 2022

    Report

    Report Number
    1038671-2022-00972
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    July 21, 2022
    Report Date
    October 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307781
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS MEDICAL DEVICES: 02-020-13-0340, TRULIANT CR CEM FEM CR CEM RIGHT SZ 4, K170240, (B)(4).

    Additional Manufacturer Narrative · 0

    D4: SERIAL AND EXPIRATION DATE CORRECTED. H4: MANUFACTURING DATE CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 63 YO MALE PATIENT, 102 KG, WHO WAS INITIALLY IMPLANTED ON (B)(6) 2022, FOR THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS, REPORTED INCREASED PAIN IN THE CLINIC ON (B)(6) 2022. XRAYS SHOWED THE PATELLA TO BE HIGH-RIDING. SURGEON DETERMINED THE PATELLA TENDON HAD RUPTURED, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED WITH EXACTECH DEVICES. PATELLA TENDON REPAIRED. THE CASE REPORT INDICATES THE EVENT IS POSSIBLY RELATED TO THE PROCEDURE AND DEFINITELY NOT RELATED TO THE DEVICE. 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 CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITIONS AND A RUPTURED PATELLA TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314818 TRULIANT TIB IMP CRC INSERT SZ 4, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 15MM UNK 10885862307781

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R SEE H10.