BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 5, 17MM

    MDR report key: 19655644 · Received July 2, 2024

    Report

    Report Number
    1038671-2024-02255
    Event Type
    Injury
    Date Received
    July 2, 2024
    Report Date
    November 15, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862266262
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6) 02-012-60-1616 - TRU STEM EXT 16MM X 160MM. (B)(6) 02-012-61-2000 - TRU OFFSET STEM EXT COUPLER, 2MM. (B)(6) 02-012-42-5008 - LOGIC PTS, SIZE 5, 8MM. (B)(6) 02-012-61-2000 - TRU OFFSET STEM EXT COUPLER, 2MM. (B)(6) 02-012-60-1416 - TRU STEM EXT 14MM X 160MM. 5042500208-06-05 - CC DISTAL FEM AUGMENT SZ 5, 10MM. (B)(6) 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM. (B)(6) 02-010-06-0350 - TRU CC FEMORAL SIZE 5 RIGHT. (5374497)02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM. 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.

    Additional Manufacturer Narrative · 0

    B1: UPDATED. B2: UPDATED. H6: CORRECTED HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PROSTHESIS WEAR, JOINT PAIN, SWELLING AND STIFFNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601826 LOGIC CC TIB INSERT SIZE 5, 17MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862266262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.