BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 9MM

    MDR report key: 18702238 · Received February 14, 2024

    Report

    Report Number
    1038671-2024-00215
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    December 28, 2017
    Report Date
    February 10, 2026
    Manufacturer
    EXACTECH INC.
    Product Code
    JWH
    UDI-DI
    10885862304438
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6: IMPACT CODE AND TYPE OF INVESTIGATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, B3: REMOVED ERRONEOUS ENTRY, B5, E4: REMOVED ERRONEOUS ENTRY, G1, G2: CONSUMER, H6: CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS. THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS/ PHOTOGRAPHS AND OPERATIVE NOTES 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

    PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS - PRODUCT INFORMATION: 4894852 200-02-35 - THREE PEG PATELLA 35MM; 5129795 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T; 5165848 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4; 5168121 204-70-00 - TIBIAL STEM EXT. SCREW; 5174639 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. UPDATED/ADDITIONAL INFORMATION ¿THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS/ PHOTOGRAPHS AND OPERATIVE NOTES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING PAIN, WEAKNESS, STIFFNESS, DISCOMFORT, AMBULATION DIFFICULTIES AND PROSTHESIS WEAR. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414470 TRULIANT TIB IMP PS INSERT SZ 4 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH INC. 10885862304438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R SEE H10.| UNK.