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: 8764335 · Received July 5, 2019

    Report

    Report Number
    3005180920-2019-00548
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    June 7, 2019
    Report Date
    June 7, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JUN 2019: LOT 184382: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2018. EXPIRATION DATE: 24-SEPT-2023. 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 DEVICE INVOLVED: LOT 182637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 03-JUL-2023. 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 · 1

    AFTER THE COMPLETION OF THE PRIMARY HIP SURGERY AND WHILE THE PATIENT WAS IN THE RECOVERY ROOM, THE HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD S WITH A 36MM BIOLOX DELTA HEAD L HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USED A SUPERIOR CAPSULOTOMY APPROACH IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558640 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S CERAMIC HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 184382 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention