BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 3, 9MM

    MDR report key: 19029985 · Received April 3, 2024

    Report

    Report Number
    1038671-2024-00723
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    October 17, 2023
    Report Date
    November 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174345
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 07 0015 13 047 (B)(6) - GPS KNEE IMPLANT KIT. (B)(6) 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3. (B)(6) 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 203-96-21 - ((B)(6)) STRYKER 2000 90X13/21X 1.9MM * THESE DEVICES ARE USED IN TREATMENT AND NOT IN DIAGNOSIS. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6: TYPE OF INVESTIGATION. INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE FOLLOWING SECTIONS WERE CORRECTED: H6: HEALTH EFFECT - CLINICAL CODE. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 9 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE. PER OPERATIVE REPORT DATED (B)(6) 2023: INTRAOPERATIVE FINDINGS SHOWED SYNOVITIS CONSISTENT WITH POLYETHYLENE WEAR DEBRIS; VISUAL INSPECTION OF THE IMPLANT SUGGESTED SOME POSTERIOR MEDIAL WEAR BUT SURFACE FINDINGS WERE MILD COMPARED TO THE DEGREE OF DEBRIS FORMATION. FEMORAL TIBIAL AND PATELLAR COMPONENTS WERE IN GOOD POSITION AND WELL FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822169 LOGIC CR TIB INSERT STD, SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174345

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention SEE H10