BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    MDR report key: 17587661 · Received August 21, 2023

    Report

    Report Number
    1038671-2023-02000
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    December 14, 2022
    Report Date
    July 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174482
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: (B)(6), 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4; (B)(6), 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, G THE REASON FOR THE REPORTED REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO 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

    IT WAS REPORTED THAT A 65 YO MALE, INITIAL RIGHT KNEE IMPLANTED ON (B)(6), 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2022, APPROXIMATELY 5 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. REASON FOR REVISION NOT REPORTED. POLY SWAP INDICATED. NO DEVICE BREAKAGE OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO DEVICE RETURNS AVAILABLE AS THE HOSPITAL KEPT THE DEVICE. NO FURTHER INFORMATION. PATIENT WAS REVISED TO EXACTECH DEVICES. (B)(6), 02-012-48-4009 - LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM; SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K111400. CONCOMITANTS: (B)(6), 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4; (B)(6), 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; (B)(6), 200-02-35 - THREE PEG PATELLA 35MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383216 LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM UNK 10885862174482

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention SEE H10