BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM LEFT SZ 5

    MDR report key: 16465213 · Received March 2, 2023

    Report

    Report Number
    1038671-2023-00332
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    August 29, 2022
    Report Date
    May 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304612
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMORAL TIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: 6193162, 02-022-45-5040, TRULIANT TIB FIT TRAY CEM SZ 5F / 4T. 6374373, 02-020-11-0250, TRULIANT PS CEM FEM PS CEM LEFT SZ 5. 6691597, 02-012-60-1440, LOGIC STEM EXT 14MM X 40MM. 6774195, 204-70-00, TIBIAL STEM EXT. SCREW. 7182839, 200-07-32, ADVANCED PATELLA 32MM 3 PEG IMPLANT. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AS A RESULT OF ADDITIONAL INFORMATION RECEIVED, THE FOLLOWING FIELDS HAVE BEEN UPDATED: A2, A3, AND B5. H6: INVESTIGATION RESULTS - THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING AS STATED IN THE OPERATIVE NOTES. THE FEMORAL LOOSENING MAY HAVE BEEN THE RESULT OF FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, WHICH LED TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE. HOWEVER, THIS CANNOT BE CONFIRMED AS THERE WERE NO DETAILS REGARDING CEMENTING TECHNIQUE OR ENVIRONMENTAL CONDITIONS PROVIDED. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND PRE-REVISION RADIOGRAPHS AND IMAGES OF THE EXPLANTED DEVICES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, WHO HAD AN INITIAL LEFT KNEE IMPLANTED WITH AN OPTETRAK DEVICE ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 MONTHS POST THE INITIAL PROCEDURE DUE TO WORSENING PAIN AND INSTABILITY. UPON INFORMATION AND BELIEF, THE LOOSE COMPONENTS, SIGNIFICANT SYNOVITIS WERE DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. AS A DIRECT, PROXIMATE AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE AS DESCRIBED HEREIN, THE PLAINTIFF 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. 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; AND PAIN AND SUFFERING. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2022. DUE TO ADVANCED DEGENERATIVE JOINT DISEASE, LEFT KNEE, VARUS DEFORMITY, FLEXION CONTRACTURE. THEY WERE SUBSEQUENTLY REVISED ON (B)(6) 2022, APPROXIMATELY 3 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT STATES THAT THE PATIENT INDICATED FOR SURGERY DUE TO PAIN, INSTABILITY, AND SWELLING. THE REPORT FURTHER STATES THAT THE LOOSENING OF THE FEMORAL COMPONENT WAS NOTED. FEMORAL COMPONENT HAD NO FIXATION TO THE CEMENT, BUT CEMENT HAD A GOOD FIXATION TO-THE BONE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541104 TRULIANT PS CEM FEM PS CEM LEFT SZ 5 SEE H10 JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 9MM UNK 10885862304612

    Patients

    Seq Age Sex Outcome Treatment
    1