BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM

    MDR report key: 18265660 · Received December 5, 2023

    Report

    Report Number
    1038671-2023-02906
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 13, 2023
    Report Date
    April 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144331
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): (B)(6), 02-010-03-0215 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5. (B)(6) 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5. (B)(6) 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. (B)(6) 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. THIS MAY HAVE BEEN POTENTIALLY CAUSED FROM INSTABILITY AND MALALIGNMENT OF EITHER THE FEMORAL AND/OR TIBIAL COMPONENT BUT CANNOT BE CONFIRMED FROM THE PROVIDED IMAGES AND PROVIDED RADIOGRAPHS. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE 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. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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 THIS PATIENT PRESENTED TO SURGEONS OFFICE WITH PAIN. SIGNIFICANT POLY WEAR WAS NOTED WITH EXCHANGE. NO ISSUES WITH SURGERY. EXPLANT NOT AVAILABLE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235235 LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862144331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown