BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    MDR report key: 16706840 · Received April 10, 2023

    Report

    Report Number
    1038671-2023-00630
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    January 24, 2023
    Report Date
    December 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001924
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, 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. 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

    LEGAL CASE - (B)(6). RELATED CASE (B)(4). PER INFORMATION RECEIVED FROM LEGAL DEPARTMENT, THE PATIENT HAD A RIGHT KNEE & LEFT KNEE REPLACEMENT ON (B)(6) 2011. THE PATIENT HAD RIGHT KNEE & LEFT KNEE REVISION (B)(6) 2023 (OP REPORT ATTACHED). POST OPERATIVE DIAGNOSIS WAS DEBRIS SYNOVITIS IN BOTH KNEES. SERIAL #: (B)(4), CATEGORY #: 02-012-35-5009 - LOGIC TIBIA PS MOD INSRT SZ 5 9MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883. CONCOMITANTS: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795318 LOGIC TIBIA PS MOD INSRT SZ 5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 9MM UNK 10885862001924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention UNK.