BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 1, 11MM

    MDR report key: 17177427 · Received June 21, 2023

    Report

    Report Number
    1038671-2023-01429
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 1, 2023
    Report Date
    July 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174185
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 2512506 02-010-03-0310 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1. 2316397 02-012-45-1020 - LGC TIBIAL FIT TRAY CEM SZ 1F / 2T. 4791230 200-02-29 - THREE PEG PATELLA 29MM. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REASON FOR THE REPORTED REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, AND/OR PATIENT RELATED FACTORS. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION, IMAGES, OR 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, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT WAS REVISED ON AN UNKNOWN DATE AND THE RECALLED POLY WAS REPLACED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012417 LOGIC CR TIB INSERT SLOPE+, SZ 1, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-48-1011 10885862174185

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention SEE H10