BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 5 11MM

    MDR report key: 16964182 · Received May 19, 2023

    Report

    Report Number
    1038671-2023-01048
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    March 1, 2021
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304636
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 6693719, 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM. 6608185, 02-020-11-0350 - RULIANT PS CEM FEM PS CEM RIGHT SZ 5. 6666469, 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T. 6606281, 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. 6619824, 204-70-00 - TIBIAL STEM EXT. SCREW. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3: THE CAUSE OF THE PATIENT¿S INSTABILITY CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - H7 & H9 SN (B)(6); CAT# 02-022-35-5011 - TRULIANT TIB IMP PS INSERT SZ 5 11MM NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3, H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, G, E. THE REASON FOR THE REPORTED EVENT 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 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON 1 MAR 2021. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: SWELLING, LOOSENESS, AND KNOCKING. 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. CONCOMITANTS: 6693719, 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM. 6608185, 02-020-11-0350 - RULIANT PS CEM FEM PS CEM RIGHT SZ 5. 6666469, 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T. 6606281, 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. 6619824, 204-70-00 - TIBIAL STEM EXT. SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852779 TRULIANT TIB IMP PS INSERT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 11MM UNK 10885862304636

    Patients

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