BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC PSC TIB INS SZ 5 17MM

    MDR report key: 17129033 · Received June 14, 2023

    Report

    Report Number
    1038671-2023-01346
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    January 16, 2023
    Report Date
    November 21, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862248183
    PMA / PMN Number
    K132161
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 16022301 660-01-10 - OSSILIX / FORM 10CC CALCIUM PHOSPHATE. 4124267 02-012-60-2012 - TRU STEM EXT 20MM X 120MM. 4231073 02-010-06-0250 - TRU CC FEMORAL SIZE 5 LEFT. 4243473 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM. 4417040 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM. 4417041 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM. 4845810 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM. 4872346 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM. 4901712 200-02-38 - THREE PEG PATELLA 38MM. 4954951 02-012-60-1212 - TRU STEM EXT 12MM X 120MM. 5022823 204-70-00 - TIBIAL STEM EXT. SCREW. 5118737 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04460, 1038671-2024-04459. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REVISION (B)(6)2017. THEY HAD LEFT KNEE REVISION ON (B)(6)2023, APPROXIMATELY 5 YEARS 2 MONTHS AFTER THEIR INITIAL PROCEDURE. THERE WAS FOUND TO BE A LOOSE TIBIAL COMPONENT WITH A COMPLETELY LOOSE TIBIAL STEM. THERE WAS FOUND TO BE A MODERATE AMOUNT OF POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE. THERE WAS EVIDENCE OF POLYETHYLENE WEAR AND SYNOVIAL ENCAPSULATION. THERE WAS A HETEROTOPIC BONE FORMED AROUND THE PATELLA WITH A LOOSE PATELLAR COMPONENT. THE PATIENT ALSO HAD DEVELOPED A PRETIBIAL GANGLION CYST DUE TO THE LOOSE TIBIAL COMPONENT RUBBING UP AGAINST THE ANTERIOR CORTEX OF HIS MID LEFT TIBIA. 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
    1281379 LOGIC PSC TIB INS SZ 5 17MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-44-5017 UNK 10885862248183

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention