BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S

    MDR report key: 18063342 · Received November 3, 2023

    Report

    Report Number
    3005180920-2023-00851
    Event Type
    Injury
    Date Received
    November 3, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 3, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 OCTOBER 2023 LOT 2303248: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MARC-2023. EXPIRATION DATE: 2028-02-16. 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. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2242600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2022. EXPIRATION DATE: 2027-11-29. 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

    AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149278 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2303248 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention