BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE COMPONENTS

    MDR report key: 21307026 · Received February 4, 2025

    Report

    Report Number
    1038671-2025-00644
    Event Type
    Injury
    Date Received
    February 4, 2025
    Report Date
    April 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. D10: A10012 - GPS IMPLANT KIT V2 (B)(6) 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4 (B)(6) 02-012-47-4009 - LOGIC CR TIB INSERT STD, SZ 4, 9MM (B)(6) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK (B)(6) 201-78-81 - 3 TROCAR, MOD. HEX 2PK (B)(6) 200-02-38 - THREE PEG PATELLA 38MM (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6) 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS (B)(6) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED (B)(6). IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    E1 PHONE NUMBER: (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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

    PATIENT STATED THEY WERE EXPERIENCING PAIN AS A RESULT OF THEIR KNEE REPLACEMENT SURGERY AND PLANS TO SEEK FURTHER MEDICAL CARE FOR THESE ISSUES. INITIAL PROCEDURE DATE UNKNOWN. UNKNOWN IF REVISION PROCEDURE WAS PERFORMED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53623 UNKNOWN KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11