BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5, 15MM

    MDR report key: 19430553 · Received May 30, 2024

    Report

    Report Number
    1038671-2024-01618
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    March 28, 2022
    Report Date
    October 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS - PRODUCT INFORMATION: 7091993 - 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED HEALTH EFFECT CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT 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 A RIGHT 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
    1151080 TRULIANT TIB IMP CRC INSERT SZ 3.5, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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