BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE COMPONENT

    MDR report key: 21095354 · Received January 7, 2025

    Report

    Report Number
    1038671-2025-00126
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    January 6, 2025
    Report Date
    April 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 204-62-05 - TIBIAL AUGMENT BLOCK 1/2-SZ 2 5MM, 2813099; 204-62-05 - TIBIAL AUGMENT BLOCK 1/2-SZ 2 5MM, 2978352; 208-22-11 - CC TIBIAL INSERT SZ 2, 11MM, 3782518; 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM, 4009937; 208-01-02 - CC FEMORAL SZ 2, 4345061; 02-012-60-1080 - TRU STEM EXT 10MM X 80MM, 4884137; 02-012-60-1280 - TRU STEM EXT 12MM X 80MM, 4942502; 200-02-32 - THREE PEG PATELLA 32MM, 4970798; 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE, 5033555; 208-07-02 - CC POSTERIOR FEM AUGMENT SZ 2, 5MM, 5059485; 204-04-22 - TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T 5230276; 200-02-32 - THREE PEG PATELLA 32MM, 5343836.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3: 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. THE FOLLOWING SECTIONS WERE CORRECTED: B3: EVENT DATE DOES NOT APPLY. G2 - OTHER/LEGAL NOTIFICATION DOES NOT APPLY. H6 - PROBLEM CODE, INVESTIGATION TYPE, FINDINGS, CONCLUSION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1: BRAND NAME UNKNOWN G1 H6: COMPONENT CODE 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 VIA A LEGAL INQUIRY, THAT A 57 YO FEMALE PATIENT, INITIAL KNEE IMPLANTED IN (B)(6) 2018, INDICATED THEY HAD A DEFECTIVE KNEE REPLACEMENT. A FUTURE REVISION DATE OF (B)(6) 2025, WAS STATED IN THE INQUIRY. NO FURTHER INFORMATION KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105747 UNKNOWN KNEE COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention SEE H11.