BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 4, 11MM

    MDR report key: 19169045 · Received April 23, 2024

    Report

    Report Number
    1038671-2024-00956
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    March 18, 2024
    Report Date
    August 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306487
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: 6349996 - 02-020-13-0340 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 4. 5639693 - 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T. M007912 - 02-022-47-4011 - TRULIANT TIB IMP CR INS STD SZ 4, 11MM. 7031880 - 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, IMPACT CODE, DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    AS REPORTED, THE SURGEON HAD A FEMALE PATIENT THAT CAME IN WITH A SMALL NON DISPLACED DISTAL FEMUR FRACTURE ON THE MEDIAL SIDE OF THE FEMUR THAT HAD A TRULIANT TOTAL RIGHT KNEE IMPLANTED ON (B)(6) 2021. THE SURGEON SAID THE PATIENT KNEW SHE WAS PART OF THE POLY RECALL AND STATED SHE FELL BECAUSE HER KNEE WAS UNSTABLE "BECAUSE OF THE RECALL". DURING SURGERY A COMPETITOR'S RETROGRADE NAIL WAS USED TO REPAIR THE FRACTURE. THE TOTAL KNEE COMPONENTS WERE WILL FIXED AND THE POLY INSERT WAS REMOVED. THERE WERE NO SIGNS OF WEAR ON THE POLY AND IT HAD NO NOTICEABLE OXIDATION OR DELAMINATION. A NEW ACTIVIT-E SZ 4, 12MM POLY WAS INSERTED AND IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES OF THE LINER WERE TAKEN. PHOTOS/X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO POLY WAS KEPT AFTER CASE CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381856 TRULIANT TIB IMP CR INS STD SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 4, 11MM UNK 10885862306487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention ADVANCED PATELLA 32MM 3 PEG IMPLANT| SEE H11| TRULIANT CR CEM FEM CR CEM RIGHT SZ 4| TRULIANT TIB FIT TRAY CEM SZ 4F/4T| TRULIANT TIB IMP CR INS STD SZ 4, 11 MM