BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 11MM

    MDR report key: 21305464 · Received February 4, 2025

    Report

    Report Number
    1038671-2025-00638
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    March 6, 2019
    Report Date
    March 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304452
    PMA / PMN Number
    K152170
    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 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. 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: B5 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

    D10 CONCOMITANT DEVICES: (5151713) 201-78-89 - 3"" DRILL BIT, MOD. HEX 2 PACK; (5151718) 201-78-89 - 3"" DRILL BIT, MOD. HEX 2 PACK; (5171755) 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F/4T; (5198437) 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4; (5200359) 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT; (5200870) 201-78-82 - COLLAR FIXATION PIN 2PK 40 MM, QUICK RELEASE. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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 THAT A PATIENT STATED THEY UNDERWENT A KNEE REPLACEMENT AND HAVE HAD TROUBLE WITH THE KNEE FOR 6 YEARS. DATABASE SEARCH FOUND THEY UNDERWENT A REVISION PROCEDURE. REVISION PROCEDURE PERFORMED APPROXIMATELY 13 MONTHS AFTER INITIAL RIGHT KNEE PROCEDURE. NO FURTHER INFORMATION KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT STATED THEY UNDERWENT A KNEE REPLACEMENT AND HAVE HAD TROUBLE WITH THE KNEE FOR 6 YEARS. DATABASE SEARCH FOUND THEY UNDERWENT A REVISION PROCEDURE. INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2018, REVISION PROCEDURE IN (B)(6) 2019. NO FURTHER INFORMATION KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094353 TRULIANT TIB IMP PS INSERT SZ 4 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304452

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R SEE H11