BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 3

    MDR report key: 17135306 · Received June 15, 2023

    Report

    Report Number
    1038671-2023-01357
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 15, 2023
    Report Date
    February 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314543
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (UNKNOWN WHICH IS LEFT OR RIGHT) (B)(6); 02-020-11-0230 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3. (B)(6); 02-022-35-3012 - TRULIANT TIB IMP PS INSERT SZ 3 12MM. (B)(6); 02-022-35-3013 - TRULIANT TIB IMP PS INSERT SZ 3 13MM. (B)(6); 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T. (B)(6); 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T. (B)(6); 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. (B)(6); 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. H7: Z-0023-2022 FOR 5121615; 02-022-35-3012 - TRULIANT TIB IMP PS INSERT SZ 3 12MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED MAY BE THE RESULT OF FEMORAL LOOSENING AND PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE BONE, MAY HAVE LEAD TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMUR AND RECALLED POLY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102760 TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-020-11-0330 10885862314543

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H SEE H10.