BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM

    MDR report key: 17261939 · Received July 5, 2023

    Report

    Report Number
    1038671-2023-01549
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    November 10, 2022
    Report Date
    December 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173645
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T 5770944 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 6221184 200-02-38 - THREE PEG PATELLA 38MM 6204810.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3, H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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 VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2020. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 2 YEARS 10 MONTHS AFTER THEIR INITIAL IMPLANTATION. (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE. PATIENT HAD SEVERE SYNOVIAL EXPANSION WITH THE APPEARANCE OF FOREIGN BODY REACTION-TYPE TISSUE, AND THE POLYETHYLENE INSERT SHOWED PITTING WEAR ON ALL SURFACES. THERE WAS NO GROSS DELAMINATION, BUT THERE WAS SEVERE PITTING AND LOSS OF SURFACE SUBSTANCE, BOTH MEDIAL AND LATERALLY ON THE INSERT. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. 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
    1788101 LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-44-4011 UNK 10885862173645

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention SEE H10.