BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 3.5, 13MM

    MDR report key: 15216238 · Received August 12, 2022

    Report

    Report Number
    1038671-2022-00912
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 13, 2022
    Report Date
    November 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305213
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPITAL IS KEEPING THE DEVICES. CONCOMITANTS MEDICAL DEVICES: 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM 6692318, 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5 6574008, 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T 6576806, 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT 6737274, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 6800956, 201-78-81 - 3" TROCAR, MOD. HEX 2PK 6743637, 204-70-00 - TIBIAL STEM EXT. SCREW 6827100. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: B5, H6, H7, H9.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION. UNSTABLE KNEE AND POSTERIOR POLY WEAR WERE INDICATED. THE 13PSC WAS SWAPPED TO 17PSC. INITIAL IMPLANT DATE IS UNKNOWN. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED IMPLANTS ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL IS KEEPING THEM.

    Description of Event or Problem · 0

    THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. PATIENT WAS INITIALLY IMPLANTED ON (B)(6), 2021, AND THE REVISION WAS APPROXIMATELY 1 YEAR 4 MONTHS POST THE INITIAL IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602717 TRULIANT TIB IMP PSC INSERT SZ 3.5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3.5, 13MM UNK 10885862305213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10