BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM

    MDR report key: 17096815 · Received June 9, 2023

    Report

    Report Number
    1038671-2023-01299
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    November 29, 2022
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174598
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4441672 02-010-03-0250 - LOGIC CR FEMORAL CEM, LEFT, SZ 5, 4738235 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T, AND 4161344 200-02-38 - THREE PEG PATELLA 38MM. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0021-2022. 1038671-2025-00019 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2025-00019. D10: CONCOMITANTS: 4441672 02-010-03-0250 - LOGIC CR FEMORAL CEM, LEFT, SZ 5; 4738235 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F/5T; 4161344 200-02-38 - THREE PEG PATELLA 38 MM. 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

    AS REPORTED VIA LEGAL DOCUMENTATION A 61 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO EFFUSION AND DISCOMFORT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED LEFT KNEE WITH POLYETHYLENE WEAR THERE WAS NO METALLOSIS OR PURULENCE PRESENT WITH THE SYNOVIAL FLUID AND NO EVIDENCE OF IMPINGEMENT OF THE METALLIC IMPLANT CEMENT AND THE METALLIC IMPLANTS WERE DEEMED COMPETENT. THE PATIENT WAS AWOKEN AND TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS OCCURRED THROUGHOUT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435804 LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM UNK 10885862174598

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R SEE H10| SEE H11