BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 20139818 · Received September 4, 2024

    Report

    Report Number
    1038671-2024-03289
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 2, 2024
    Report Date
    December 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 5841450 02-010-01-0350 - LGC FEMORAL PS CEM RIGHT SZ 5. 3520508 02-012-38-5011 - LGC TIBIA PS RBK INSRT SZ 5 11MM. 4994262 02-012-43-5050 - LGC TIBIA RBKTRAY CEM SZ 5F/ 5T. 6012383 200-02-41 - THREE PEG PATELLA 41MM. 6044586 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 5851797 201-78-81 - 3 TROCAR, MOD. HEX 2PK. 5W362 203-96-22 - (3110) STRYKER 2000 90X19X 1.19MM. 6026863 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM. 5843696 204-70-00 - TIBIAL STEM EXT. SCREW. 5330156 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 5415705 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S019844 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. S016798 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. 05017019173 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. G4: 510K UNKNOWN DUE TO THE SPECIFIC DEVICE NOT BEING REPORTED THE FOLLOWING SECTIONS WERE UPDATED: H6 THE FOLLOWING SECTIONS WERE CORRECTED: B2 H6 THE REASON FOR THE REVISION REPORTED MAY HAVE BEEN DUE TO THE REPORTED PAIN. HOWEVER, THE REASON FOR THE PAIN CANNOT BE CONCLUSIVELY DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR 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

    IT WAS REPORTED THAT THIS 57 Y/O MALE PATIENT'S KNEE WAS REVISED APPROXIMATELY 5 YEARS POST OP. PATIENT PRESENTED WITH PAIN AND SURGEON DECIDED TO CONDUCT A REVISION SURGERY. EVERYTHING WAS REMOVED AND REPLACED BY A COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734526 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| H