BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 19611929 · Received June 26, 2024

    Report

    Report Number
    3005180920-2024-00458
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A RANDOM MDR CHECK CONDUCTED ON OCTOBER 1, 2024, AN ERROR WAS NOTICED. A FOLLOW-UP IS BEING INITIATED TO CORRECT IT. D1 BRAND NAME CORRECTED. D4 MODEL NUMBER INSERTED IN THE CORRECT FIELD. D4 EXPIRATION DATE CORRECTED.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 JUNE 2024. LOT 2401464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2024. EXPIRATION DATE: 2029-JAN-14. 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. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.4048HC10A FACE-CHANGING 10° PE HC LINER Ø40/F (K183582) LOT 2401971: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2024. EXPIRATION DATE: 2029-FEB-26. 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

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 11 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595805 MECTACER BIOLOX DELTA FEMORAL BALL HEAD HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.213 2401464 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention