BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 3, 15MM

    MDR report key: 18885592 · Received March 12, 2024

    Report

    Report Number
    1038671-2024-00477
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    May 22, 2023
    Report Date
    October 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862266019
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED MANUFACTURER NARRATIVE: THE REASON FOR THE REVISION REPORTED IN (B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR. THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED. 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. ADDITIONALLY, THIS DEVICE WAS PACKAGED AFTER INITIATION OF THE RECALL AND WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-010-06-0230 - TRU CC FEMORAL SIZE 3 LEFT, 6593194. 02-012-60-1680 - TRU STEM EXT 16MM X 80MM, 6614314. 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM, 7030343. 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM, 7030344. CS-05CC - INTERSEP CALCIUM SULFATE 19091. THESE DEVICES ARE USED FOR TREATMENT AND NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 10 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222385 LOGIC CC TIB INSERT SIZE 3, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862266019

    Patients

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