BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT

    MDR report key: 16432517 · Received February 23, 2023

    Report

    Report Number
    1038671-2023-00213
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    July 22, 2021
    Report Date
    June 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305305
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D1, D4 ALL, D10, G 4 510K, H4, H7 & H9. D10. CONCOMITANTS: 6673570; 02-010-06-0240 - LOGIC CC FEMORAL SIZE 4, LEFT. 6018494; 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM. 6765266; 02-012-61-4000 - LOGIC OFFSET STEM EXT COUPLER 4MM. 5132191; 02-012-64-1612 - TRU FLUTED STM EXT 16MM X120MM BLAST. 6693763; 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, B7 H6, INVESTIGATION FINDINGS. H6. 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 PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCTS: (B)(4) 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4; (B)(4) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; (B)(4) 200-02-38 - THREE PEG PATELLA 38MM; (B)(4) 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM; (B)(4) 204-70-00 - TIBIAL STEM EXT. SCREW. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2025-02234. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INFECTION AND INSTABILITY OR DUE TO 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 AND RADIOGRAPHS WERE NOT PROVIDED. 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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2021 AND WAS IMPLANTED WITH ANOTHER RECALLED EXACTECH OPTETRAK DEVICE. ON (B)(6) 2021 PLAINTIFF UNDERWENT ANOTHER REVISION SURGERY, APPROXIMATELY 1 MONTH POST REVISION PROCEDURE, AND WAS AGAIN IMPLANTED WITH AN EXACTECH OPTETRAK DEVICE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, UNDERWENT A REVISION PROCEDURE. APPROXIMATELY 1 MONTH POST REVISION PROCEDURE, AND THE PATIENT UNDERWENT A SECOND REVISION PROCEDURE TO ADDRESS PAIN, RECURRENT EFFUSIONS, AND AN INFECTION. PRE-SURGERY, THE PATIENT'S KNEE WAS ASPIRATED. HIS CELL COUNT WAS FOUND TO BE 38,500 AND HE WAS GROWING STAPHYLOCOCCUS LUGDUNENSIS. REVISION OPERATIVE NOTES WERE PROVIDED. THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND POLYETHYLENE EXCHANGE. THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO COMPLICATIONS, AND HE WAS TRANSFERRED TO THE PACU IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446156 TRULIANT TIB IMP PSC INSERT SEE H10 JWH EXACTECH, INC. UNK UNK 10885862305305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.| SEE H10.