BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM

    MDR report key: 19306593 · Received May 13, 2024

    Report

    Report Number
    1038671-2024-01222
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 22, 2024
    Report Date
    August 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306425
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 6172622 02-020-13-0335 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5 5657649 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T 6186720 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO THE INSTABILITY OR DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. INSTABILITY MAY BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESIS. PROSTHESIS WEAR OF THE TIBIAL INSERT AND THE PATELLA, COULD NOT BE CONFIRMED FROM THE PROVIDED IMAGES. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 67 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 3 YEARS 9 MONTHS POST OP. THE PATIENT HAD AN ORIGINAL EXACTECH TKA. THE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024. THE PATIENT UNDERWENT POLY TIBIAL INSERT SWAP AND PATELLA SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591510 TRULIANT TIB IMP CR INS STD SZ 3.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862306425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10