BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M

    MDR report key: 14698597 · Received June 15, 2022

    Report

    Report Number
    3005180920-2022-00452
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 15, 2022
    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

    BATCH REVIEW PERFORMED ON 18 MAY 2022. LOT 2007651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2020. EXPIRATION DATE: 2025-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT INVOLVED: BATCH REVIEW PERFORMED ON 18 MAY 2022. LINER: IMPACT 01.32.4048HCT FLAT PE HC LINER 40/F (K122641) LOT 2013107: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2021. EXPIRATION DATE: 2026-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD 1 YEAR AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657509 BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.213 2007651 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention