BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2.5 10MM

    MDR report key: 18967638 · Received March 25, 2024

    Report

    Report Number
    1038671-2024-00655
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    October 1, 2023
    Report Date
    November 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304179
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE REASON FOR THE REPORTED EVENT IN (B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND INSTABILITY AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    H10. IMPLANTED DEVICE WAS NOT IDENTIFIED: M001394 02-022-35-2509 - TRULIANT TIB IMP PS INSERT SZ 2.5 9MM 5070387 02-022-35-2510 - TRULIANT TIB IMP PS INSERT SZ 2.5 10MM M005691 02-022-35-2510 - TRULIANT TIB IMP PS INSERT SZ 2.5 10MM IT IS NOT POSSIBLE TO DETERMINE THE INSERT - THE INVOICE NUMBER IS THE SAME AND THE LEFT AND RIGHT FEMORAL COMPONENT ARE THE SAME SIZE - SO WE CANNOT DETERMINE THE INSERT BECASUE THE ARE THE SAME SIZE CONCOMITANT: 5064530 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5 5487021 02-020-11-0325 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5 5371638 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T 5509010 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T 5394455 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT 5417570 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT 5020076 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK THESE DEVICES ARE USED IN TREATMENT AND NOT FOR DIAGNOSIS. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018. THE PATIENT HAS NOT BEEN SURGICALLY REVISED. THERE IS NO OTHER PATIENT OR MEDICAL INFORMATION PROVIDED. THERE ARE NO IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAD SIMULTANEOUS BILATERAL KNEE REPLACEMENTS, THE SEARCHABLE INFORMATION DOES NOT CLARIFY THE DEVICE THAT WAS ACTUALLY IMPLANTED. 02-022-35-2510 IS A REASONABLE SELECTION OF DEVICE/Z-0023-2022 [OUT OF 3 DEVICES 2 ARE 10MM INSERTS].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614 TRULIANT TIB IMP PS INSERT SZ 2.5 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304179

    Patients

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