BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4

    MDR report key: 17825076 · Received September 27, 2023

    Report

    Report Number
    3005180920-2023-00750
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    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 11-SEPT-2023: LOT 2203058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-04-27. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 11-SEPT-2023: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2202301: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2022. EXPIRATION DATE: 2027-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS FROM THE PRIMARY, 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 HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973083 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2203058 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention