BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2.5 9MM

    MDR report key: 16590352 · Received March 22, 2023

    Report

    Report Number
    1038671-2023-00485
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    February 9, 2023
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304162
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 5026506 02-022-45-2515 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 1.5T. 5886648 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. 6220127 02-020-11-0325 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5. INFORMATION NOT PROVIDED IN THIS REPORT WAS NOT AVAILABLE AT TIME OF SUBMISSION.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0023-2022 1038671-2025-00016 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0023-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2025-00016. D10: CONCOMITANTS: (B)(6) 02-022-45-2515 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 1.5T. (B)(6) 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. (B)(6) 02-020-11-0325 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, OR THE TRAUMATIC FALLS, MAY HAVE LEAD TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS 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

    IT WAS REPORTED FROM LEGAL THAT ON (B)(6) 2019, THAT THE PATIENT UNDERWENT A TOTAL RIGHT KNEE REPLACEMENT AND WAS IMPLANTED WITH A TRULIANT DEVICE. IN (B)(6) 2021, THE PATIENT WAS DESCENDING A SET OF STAIRS WHEN HER KNEES GAVE OUT. SHE FELL DOWN THE STAIRS AND FRACTURED HER RIGHT ANKLE. THIS INJURY RESULTED IN SIGNIFICANT PAIN AND REQUIRED EXTENSIVE REHABILITATION. SEVERAL MONTHS LATER, THE PATIENT SUFFERED ANOTHER FALL DUE TO WEAKNESS IN HER KNEES. THIS FALL RESULTED IN A LEFT FOOT FRACTURE. ON (B)(6) 2023, THE PATIENT REPORTED THAT THE PAIN, WEAKNESS, AND POPPING IN HER KNEES HAD BECOME INCREASINGLY WORSE OVER THE PAST YEAR. THE PATIENT¿S PHYSICIAN STATED THAT ¿A REVISION OF THE IMPLANT IS INDICATED TO RELIEVE THE PATIENT¿S PAIN.¿ THE PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT REVISION SURGERY ON (B)(6) 2023. FOLLOWING THE REVISION SURGERY, THE PATIENT WAS DIAGNOSED WITH ¿FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR SECONDARY TO A RECALLED POLYETHYLENE AND FEMORAL LOOSENING.¿ THE SURGEON NOTED ¿SOME SYNOVITIS WITH PARTICULATE DEBRIS CONSISTENT WITH POLYETHYLENE WEAR OR CEMENT DISEASE.¿ THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450556 TRULIANT TIB IMP PS INSERT SZ 2.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 9MM UNK 10885862304162

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H SEE H10| SEE H11.