BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 16860940 · Received May 3, 2023

    Report

    Report Number
    1038671-2023-00890
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    March 6, 2023
    Report Date
    October 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159144
    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

    PENDING INVESTIGATION. D10. CONCOMITANTS: 4993303, 02-010-03-0225 - LOGIC CR FEMORAL CEM, LEFT SZ 2.5; 5160980, 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T; 5221286, 200-02-32 - THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    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. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2018. SHE HAD LEFT KNEE REVISION (B)(6) 2023, APPROXIMATELY 5 YEARS AFTER THEIR INITIAL PROCEDURE. POSTOPERATIVE DIAGNOSIS: LEFT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE. SURGEON NOTED THAT IT WAS IMMEDIATELY APPARENT THERE WAS A LARGE EFFUSION, WHICH WAS NONPURULENT AND NO METALOSIS PRESENT. THE SYNOVIUM WAS HYPERTROPHIC WITH BROWNISH DISCOLORATION AS WELL. THERE WAS NO DESTRUCTION OF THE POSTERIOR TIBIAL LIP OF THE TIBIAL TRAY AND OTHERWISE WAS DEEMED COMPETENT. THE POLYETHYLENE SHOWED PITTING, DELAMINATION AND DESTRUCTION OF THE LATERAL COMPARTMENT. PATELLAR POLYETHYLENE APPEARED PRISTINE, AND WAS LEFT IN. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532929 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-47-2509 UNK 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention SEE H10