BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    MDR report key: 15277257 · Received August 23, 2022

    Report

    Report Number
    1038671-2022-00953
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    January 1, 2022
    Report Date
    May 1, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304346
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5; 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T; 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH CLINICAL DATA COLLECTION ACTIVITIES, TRULIANT KNEE CLINICAL STUDY, THAT A 63 YO CAUCASIAN FEMALE, WHO HAD PRIMARY SURGERY ON HER RIGHT KNEE DUE TO OSTEOARTHRITIS, INDICATED THEY HAD PAIN IN RIGHT KNEE PATELLAR REGION AND CLICKING WHEN ASCENDING STAIRS AND WHEN BENDING RIGHT KNEE. ONSET DATE SOME TIME IN 2022 (PATELLAR CREPITUS). A RIGHT KNEE ARTHROSCOPIC WITH SYNOVECTOMY IS TO BE SCHEDULED AT THE SUBJECT'S CONVENIENCE. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND RELATED TO PROCEDURE IS UNKNOWN. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT PAIN OF PATELLAR CREPITUS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    THE RX'D RIGHT KNEE ARTHROSCOPIC WITH SYNOVECTOMY WHICH WAS TO BE SCHEDULED AT THE PATIENT'S CONVENIENCE, WAS PERFORMED ON (B)(6) 2023. THE CLINICAL STUDY INDICATES THE EVENT, "PAIN IN RIGHT KNEE PATELLAR REGION AND CLICKING WHEN ASCENDING STAIRS AND WHEN BENDING RIGHT KNEE." WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633357 TRULIANT TIB IMP PS INSERT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM UNK 10885862304346

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H10