BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 13MM

    MDR report key: 17783207 · Received September 20, 2023

    Report

    Report Number
    1038671-2023-02332
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    July 22, 2024
    Report Date
    August 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304476
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: OPTETRAK FEMORAL AUG BLOCK & SCREW (208-05-04, 4858356) OPTETRAK LOGIC FIT TIBIAL TRAY (02-012-45-4030, 5282350) OPTETRAK LOGIC STEM EXTENSION FEMORAL AND TIBIAL (02-012-60-1440, 6529292) OPTETRAK TIBIAL STEM EXTENSION SCREW (204-70-00, 6580212) OPTETRAK 3 PEG ADVANCED PATELLA (200-07-29, 6015839) OPTETRAK LOGIC FEMORAL COMPONENT (02-010-06-0240, 5553653) OPTETRAK LOGIC STEM EXTENSION FEMORAL AND TIBIAL (02-012-60-1440, 5835494) OPTETRAK FEMORAL AUG BLOCK & SCREW (208-05-04, 4858366) OPTETRAK LOGIC FEMORAL AUGMENT & SCREW POSTERIOR, CEMENTED (02-010-06-0541, 5930806) OPTETRAK LOGIC FEMORAL AUGMENT & SCREW POSTERIOR, CEMENTED (02-010-06-0541, 5702064) INITIAL SUBMISSION: ALL FIELDS IN SECTION F SHOULD BE BLANK, THIS IS A MANUFACTURER'S REPORT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D6B, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PATELLAR LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. FAILURE OF THE CEMENT USED TO SECURE THE PATELLA IMPLANT TO THE PATELLAR BONE, MAY HAVE LED TO LOOSENING AT THE CEMENT-BONE INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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 LEFT KNEE REVISION ON (B)(6) 2020. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A COMPLAINT IN A COORDINATED ACTION IN (B)(6) COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Description of Event or Problem · 0

    IT IS DOCUMENTED VIA LEGAL DOCUMENTATION APPROXIMATELY 46 MONTHS AFTER A REVISION LEFT KNEE REPLACEMENT SURGERY, THE PATIENT UNDERWENT A SECOND REVISION LEFT KNEE REPLACEMENT SURGERY. THE PATIENT EXPERIENCED LEFT ANTERIOR KNEE PAIN AND RECURRENT EFFUSIONS. A REVISION OPERATIVE REPORT WAS PROVIDED PRE-OPERATIVE WORK UP FOR INFECTION WAS NOTED TO BE NEGATIVE. X-RAYS SHOWED LOOSENING OF PATELLAR COMPONENT WITH OSTEOLYSIS. INTRAOPERATIVELY THE TIBIAL INSERT, UPON REMOVAL, WAS NOTED TO HAVE SIGNS OF OXIDATIVE CHANGES. THE FEMORAL AND TIBIAL COMPONENTS WERE NOTED TO BE WELL FIXED. THE PATELLAR COMPONENT WAS SIGNIFICANTLY LOOSE. THE SURGEON OBSERVED AND NOTED A VERY THIN PATELLA WITH CONCAVITY. IT WAS ELECTED TO PROCEED WITH BONE GRAFTING AND NOT RESURFACING. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76195 TRULIANT TIB IMP PS INSERT SZ 4 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862304476

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Required Intervention| H