BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM

    MDR report key: 15873466 · Received November 28, 2022

    Report

    Report Number
    1038671-2022-01518
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    February 24, 2022
    Report Date
    April 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174321
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 2535750 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; 2394098 200-02-35 - THREE PEG PATELLA 35MM; 2424017 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 2463075 201-78-80 - 3" TROCAR, HEX 2PK; 2535017 201-78-81 - 3" TROCAR, MOD. HEX 2PK; 2042701 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE; 11340 203-96-43 - 11-4137 SRYKER SYS 6 90X13X1.19; 1865739 213-64-41 - AXIAL PATELLA REAMER 41MM STANDARD BLADE. CORRECTION/REMOVAL NUMBER: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT ADDITION OF FEMORAL COMPONENT 2250864 02-010-03-0320 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2. REMOVAL OF TIBIAL INSERT AS THIS IS THE SUSPECT DEVICE. H3 BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. D1, D4 CATALOG #, SERIAL # AND EXPIRATION DATE F6, F8 NOT APPLICABLE, THIS IS A MANUFACTURING REPORT H4 MANUFACTURE DATE

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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 BY LEGAL, THIS FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2013. IN OR AROUND ON (B)(6) 2022, THE PATIENT WAS ADVISED THAT HER KNEE REPLACEMENT FAILED FOR REASONS RELATED TO THE DEFECTIVE DEVICE. THE PATIENT HAD A REVISION ON (B)(6) 2022 FOR ISSUES INCLUDING, BUT NOT LIMITED TO, POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, AND/OR COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676274 LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-49-2011 10885862174321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention