BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12655739 · Received October 19, 2021

    Report

    Report Number
    3005180920-2021-00816
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 28 SEPTEMBER 2021: LOT 2012923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-04-2021. EXPIRATION DATE: 2026-03-29 NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: LINER: MPACT 01.32.3648HCAT HOODED PE HC LINER Ø36/F (K132879) LOT 2005029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-08-2020. EXPIRATION DATE: 2025-07-26. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555049 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2012923 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention