BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28

    MDR report key: 20005705 · Received August 20, 2024

    Report

    Report Number
    3005180920-2024-00649
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809323
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JULY 2024. LOT 2348073: (B)(4) MANUFACTURED AND RELEASED ON 09-JAN-2024. EXPIRATION DATE: 2028-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: STEM: MASTERLOC 01.39.203 CEMENTLESS TI COATED LAT STEM SIZE 3 (K160289) LOT 2112247: (B)(4) MANUFACTURED AND RELEASED ON 10-JAN-2022. EXPIRATION DATE: 2026-12-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.STEM:

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2014. ON (B)(6) 2024 SHELL, HEAD AND LINER WERE REVISED SUCCESSFULLY. THE PATIENT LUXATED HIS HIP AND SUSTAINED A CLOSED REDUCTION, BUT AFTER THIS, IN THE X-RAYS DONE IN THE ER, IT WAS NOTICED THAT THE SHELL WAS OUT OF THE ACETABULUM BONE. IT IS UNKNOWN IF THE LUXATION WAS DUE TO THE CUP FAILURE OR IF THE CUP FAILURE WAS GENERATED DURING THE CLOSED REDUCTION. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, EXPLANTED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361928 BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28 HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2348073 07630030809323

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention