BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER HEAD BIOLOX OPTION 32

    MDR report key: 10566032 · Received September 22, 2020

    Report

    Report Number
    3005180920-2020-00629
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809330
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2020. LOT 189670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2019. EXPIRATION DATE: 2024-01-21. 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: BATCH REVIEW PERFORMED ON 02 APRIL 2020: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 1910285: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2020. EXPIRATION DATE: 2024-12-09. 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

    THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030357 MECTACER HEAD BIOLOX OPTION 32 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.231H 189670 07630030809330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention