BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 3 L

    MDR report key: 19614851 · Received June 26, 2024

    Report

    Report Number
    3005180920-2024-00470
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    May 27, 2024
    Report Date
    June 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825439
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07-JUN-2024. LOT 2313180: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 2028-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: POSTOPERATIVE FRACTURE, ON THE SAME DAY OF THE TKA SURGERY WITH A CONSTRAINED IMPLANT, DUE TO THE OSTEOPOROSIS OF THE PATIENT WHO ALSO HAS VERY SMALL BONES WHICH INDUCED A DEVIATION OF THE REAMER. NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 07-JUN-2024. GMK-HINGE 02.07.FCL14065 EXTENSION STEM - FLUTED Ø 14 L 65 (K120790) LOT 2300795: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2023. EXPIRATION DATE: 2028-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    IN THE SAME DAY AFTER THE KNEE SURGERY PERFORMED ON THE (B)(6) 2024, A POST-OP PERIPROSTHETIC BONE FRACTURE WAS OBSERVED. A FOLLOW UP VISIT WAS DONE ON THE (B)(6) 2024. ACCORDING TO THE REVISION SURGEON, THE CAUSES OF THE POSTOPERATIVE FRACTURE WERE THE PATIENT'S OSTEOPOROSIS AND FRAGILITY OF THE ANTERIOR FEMORAL CORTEX, EXACERBATED BY A FALSE ROUTE DURING REAMING. THE IMPLANTS WERE NOT INVOLVED AT THIS STAGE. REVISION OF FEMORAL COMPONENT AND EXTENSION STEM PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625736 GMK-HINGE FEMORAL COMPONENT SIZE 3 L KNEE FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 2313180 07630030825439

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| O