BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40

    MDR report key: 18648765 · Received February 6, 2024

    Report

    Report Number
    3005180920-2024-00033
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809354
    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 23 JANUARY 2024. LOT 2237507: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2022. EXPIRATION DATE: 2027-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 23 JANUARY 2024. LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT 2310981: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JULY-2023. EXPIRATION DATE: 2028-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 23 JANUARY 2024. STEM: SMS SOLID 01.36.070 SMS SOLID STEM LAT SIZE 10 (K181693) LOT 2101520: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JULY-2021. EXPIRATION DATE: 2026-05-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092403 BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40 HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2237507 07630030809354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention