BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS SLOPE+ SZ 4.5 9MM

    MDR report key: 19856261 · Received July 29, 2024

    Report

    Report Number
    1038671-2024-02577
    Event Type
    Injury
    Date Received
    July 29, 2024
    Report Date
    March 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306913
    PMA / PMN Number
    K171045
    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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, D4, G4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, E. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND LOOSENING AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION 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

    D10 CONCOMITANTS: 5232346 02-022-45-4555 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/5.5T 5783834 02-020-13-0245 - TRULIANT CR CEM FEM CR CEM LEFT SZ 4.5 5787023 200-02-35 - THREE PEG PATELLA 35MM THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL [ENTER RECALL #]; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    13. PLAINTIFF (B)(6) IS A RESIDENT AND CITIZEN OF (B)(6). 73. ON (B)(6) 2019 PLAINTIFF (B)(6) UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN INSERT MADE OF POLYETHYLENE, SERIAL NUMBER (B)(6). PLAINTIFF¿S TOTAL KNEE REPLACEMENT SURGERY WAS PERFORMED AT THE LAFAYETTE SURGICAL SPECIALTY HOSPITAL IN LAFAYETTE, LOUISIANA 74. PLAINTIFF HAS NOT YET SCHEDULED A REVISION SURGERY OF HIS LEFT TOTAL KNEE REPLACEMENT. 77. AS A DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE AS DESCRIBED HEREIN, PLAINTIFF (B)(6) HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 78. AS A FURTHER DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE, PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; LOSS OF CONSORTIUM AND PAIN AND SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004680 TRULIANT TIB IMP CR INS SLOPE+ SZ 4.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862306913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown