BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 4, 9MM

    MDR report key: 18812765 · Received February 29, 2024

    Report

    Report Number
    1038671-2024-00355
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    October 18, 2023
    Report Date
    December 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174444
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D.4 THERE WERE 2 DEVICES LISTED IN THE INVOICE FOR THIS PATIENT- IT IS UNKNOWN WHICH DEVICE WAS IMPLANTED- PRODUCT INFORMATION: 2232562 02-012-47-4009 - LOGIC CR TIB INSERT STD, SZ 4, 9MM MANUFACTURE DATE: 30-JAN-2012; EXP. DATE: 27-JAN-2020; 2538397. 02-012-47-4009 - LOGIC CR TIB INSERT STD, SZ 4, 9MM MANUFACTURE DATE: 30-NOV-2012; EXP. DATE: 28-NOV-2020; D10. CONCOMITANTS - PRODUCT INFORMATION: 2784416 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4; 2789048 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; 2792022 200-03-35 - ONE PEG PATELLA 35MM. PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    1038671-2024-04831 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G1, H6. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, G1, H6. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04831. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND PATELLAR LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 10 YEARS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023 ¿ POSTOPERATIVE DIAGNOSIS: FAILURE OF RIGHT TOTAL KNEE ARTHROPLASTY DUE TO FAILURE OF TIBIAL POLYETHYLENE AND PATELLAR BUTTON. REVISION OF TIBIAL AND PATELLAR COMPONENTS. PATIENT REVISED TO EXACTECH DEVICES. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910416 LOGIC CR TIB INSERT STD, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174444

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R SEE H10