BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM

    MDR report key: 16328971 · Received February 8, 2023

    Report

    Report Number
    1038671-2023-00125
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 9, 2023
    Report Date
    May 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230560
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: H6: UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND THERE IS NO ALLEGATION AGAINST THE DEVICE. THIS CAUSE OF THE REPORTED EVENT IS MOST LIKELY PATIENT CONDITIONS, HOWEVER; CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT: 2822825, 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 61 YO MALE PATIENT, WHO HAD AN INITIAL RIGHT KNEE REVISION PROCEDURE ON (B)(6) 2022, UNDERWENT A SECOND REVISION ON (B)(6) 2023, APPROXIMATELY 1 MONTH POST THE FIRST REVISION. THE PATIENT WAS REVISED DUE TO A SWOLLEN KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PRODUCT RETURNING. REASON NOT REPORTED. NO FURTHER INFORMATION. FIRST REVISION REPORTED UNDER REPORT NUMBER 1038671-2022-01636.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373940 LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM SEE H10 JWH EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM UNK 10885862230560

    Patients

    Seq Age Sex Outcome Treatment
    1