BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 2, 25MM

    MDR report key: 17893896 · Received October 9, 2023

    Report

    Report Number
    1038671-2023-02470
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    January 1, 2023
    Report Date
    October 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265944
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS; 02-010-06-0220 - TRU CC FEMORAL SIZE 2 LEFT (B)(6). 02-010-06-0522 - TRU POST. AUG. SIZE 2, 10MM (B)(6). 02-010-66-1002 - METAPHYSEAL FEMORAL CONE, SMALL, H42MM (B)(6). 02-012-45-2030 - LGC TIBIAL FIT TRAY CEM SZ 2F / 3T (B)(6). 02-012-60-1416 - TRU STEM EXT 14MM X 160MM (B)(6). 02-012-60-1440 - TRU STEM EXT 14MM X 40MM (B)(6). 02-012-60-1880 - TRU STEM EXT 18MM X 80MM (B)(6). 02-012-66-2000 - METAPHYSEAL TIBIAL CONE, ML32MM (B)(6). 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM (B)(6). 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM (B)(6). CS-05CC - INTERSEP CALCIUM SULFATE (B)(6). PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D4: REMOVED CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, AND UDI D10: CONCOMITANTS UNKNOWN G3: REMOVED 510K NUMBER H4: REMOVED DEVICE MANUFACTURE DATE H6: CORRECTED HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, LOSS OF RANGE OF MOTION, LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THE DEVICES WERE IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED FAILURE(S). HOWEVER, THE REPORTED PROSTHESIS WEAR, LOSS OF RANGE OF MOTION, AND LOOSENING COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO PRODUCT INFORMATION, IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THIS REVISION WAS REVISED AGAIN IN 2023 (EXACT DATE IS UNKNOWN) THE POLY INSERT HAD COMPLETELY DISINTEGRATED, SO THE TIBIA COMPLETELY CRUMBLED, AND SHE HAD TO GET A TIBIAL PLATE AND SCREWS INSERTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121238 LOGIC CC TIB INSERT SIZE 2, 25MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862265944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10