BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 11MM

    MDR report key: 17148940 · Received June 16, 2023

    Report

    Report Number
    1038671-2023-01392
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 24, 2023
    Report Date
    December 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001931
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 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 OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND 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

    PENDING INVESTIGATION. D10: 310029 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19. 3907384 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5. 4486018 200-02-41 - THREE PEG PATELLA 41MM. 5151752 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK. 5354902 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. 5390593 201-78-81 - 3" TROCAR, MOD. HEX 2PK. AB3292 13A2101 - CEMEX SYSTEM FAST GENTA 70G. H7: Z-0021-2022.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO EARLY WEAR. THE POLY WAS SWAPPED TO A 12MM PS INSERT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546283 LOGIC TIBIA PS MOD INSRT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-35-5011 10885862001931

    Patients

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