BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 16274702 · Received January 31, 2023

    Report

    Report Number
    1038671-2023-00089
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    December 20, 2017
    Report Date
    April 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304254
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 4828350, CATALOG #: 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T, 4976624, CATALOG #: 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, 4977050, CATALOG #: 02-020-11-0230 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3, 5021286, CATALOG #: 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 5037852, CATALOG #: 200-02-35 - THREE PEG PATELLA 35MM, 5081054, CATALOG #: 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK 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 REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND ACTIVITY. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REASON FOR THE SWELLING REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA AN EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 69 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, WAS SEEN ON (B)(6) 2017, REGARDING SEVERE PAIN AND A HEMATOMA FORMATION. HE HAD NOT BEEN ABLE TO REGAIN HIS ROM. HIS KNEE HAS REMAINED VERY STIFF AND PAINFUL. MUA AND REMOVAL OF KNEE SCAR TISSUE CONSIDERED IF NECESSARY. CONTINUED PHYSICAL THERAPY, USE OF DYNASPLINT, DAILY MOBIC USE WITH PROTONIX INDICATED. THE PATIENT WAS GIVEN COMPRESSION STOCKINGS TO HELP WITH SWELLING. ULTRASOUND PERFORMED. NO DEEP VEIN THROMBOSIS FOUND. HE DID HAVE RESOLVING HEMATOMA. RANGE OF MOTION EXAM AND KNEE MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2018. THE STUDY INDICATES THE EVENT IS UNLIKELY RELATED TO DEVICE, BUT POSSIBLY RELATED TO PROCEDURE. OUTCOME INDICATES RESOLVED ON (B)(6) 2018. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416282 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 9MM UNK 10885862304254

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention