BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 2, 13MM

    MDR report key: 18778723 · Received February 26, 2024

    Report

    Report Number
    1038671-2024-00317
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    April 26, 2022
    Report Date
    October 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304933
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS -PRODUCT INFORMATION: 7120904 02-010-06-0320 - TRU CC FEMORAL SIZE 2 RIGHT; 6556600 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; 6829272 02-012-60-1440 - TRU STEM EXT 14MM X 40MM; 6611642 02-012-60-1680 - TRU STEM EXT 16MM X 80MM; 6291424 02-012-61-2000 - TRU OFFSET STEM EXT COUPLER, 2MM; 6805768 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM; 6970563 204-70-00 - TIBIAL STEM EXT. SCREW PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, IMPACT CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. ADDITIONALLY, THIS DEVICE WAS PACKAGED AFTER INITIATION OF THE RECALL AND WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908563 TRULIANT TIB IMP PSC INSERT SZ 2, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304933

    Patients

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