BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM

    MDR report key: 17726513 · Received September 11, 2023

    Report

    Report Number
    1038671-2023-02237
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 9, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001269
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATION THIS HAS BEEN DISCOVERED TO BE A DUPLICATE OF MFR#1038671-2021-00433 ALL NEW INFORMATION WILL BE REPORTED AND PROCESSED UNDER MFR#1038671-2021-00433. CORRECTED INFORMATION_ B5, D1, D4 ALL, G4 510K H4, DEVICE CORRECTED TO LOGIC FEMORAL PS CEM RIGHT SZ 5, CAT# 02-010-01-0350, SN (B)(6). ALL NEW INFORMATION WILL BE REPORTED AND PROCESSED UNDER MFR#1038671-2021-00433.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: M009096 02-022-44-5010 - TRULIANT TIB IMP PSC INSERT SZ 5, 10MM. 4908095 02-010-66-2003 - METAPHYSEAL FEMORAL CONE, MEDIUM, H52MM. 6141881 02-012-60-1680 - TRU STEM EXT 16MM X 80MM. 4845863 02-012-61-2000 - TRU OFFSET STEM EXT COUPLER, 2MM. 5101449 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM. 5101450 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM. H7: Z-0023-2022 FOR M009096 02-022-44-5010 - TRULIANT TIB IMP PSC INSERT SZ 5, 10MM.

    Description of Event or Problem · 0

    RIGHT KNEE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2020. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. 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
    1145795 LOGIC FEMORAL PS CEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 10885862001269

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention