BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 9069325 · Received September 16, 2019

    Report

    Report Number
    3005180920-2019-00784
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 AUGUST 2019: LOT 189636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO OTHER SIMILAR EVENTS REPORTED. ADDITIONAL IMPLANT INVOLVED LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER 28/DME (K092265), LOT. 1810743. BATCH REVIEW PERFORMED ON 26 AUGUST 2019: LOT 1810743: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2019. EXPIRATION DATE: 2014-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVEN.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862867 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 189636 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention