BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8315270 · Received February 7, 2019

    Report

    Report Number
    3005180920-2019-00034
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 9, 2019
    Report Date
    February 7, 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 07 FEBRUARY 2019: LOT 150448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JULY 2015 . EXPIRATION DATE: 2020-05-31. 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. OTHER DEVICE INVOLVED: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28 REFERENCE 01.26.2854MHC (K092265): LOT 153656: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 OCTOBER 2015. EXPIRATION DATE: 2020-08-31. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: THREE YEARS AFTER PRIMARY CEMENTLESS THR THE PATIENT COMPLAINS OF PAIN. THE SURGEON OPENS THE JOINT AND DOES SOME CLEANING; IN DOING SO, AS PER CUSTOMARY PROCEDURE, HE REPLACED HEAD AND LINER, BUT THERE IS NO HINT THAT THESE COMPONENTS WERE MALFUNCTIONING. FROM THE XRAY, THE IMPRESSION IS OF A NEGATIVE REACTION OF THE HOST BONE, BECAUSE THE STEM SHOWS A DEMARCATION LINE ALL AROUND, WHICH IS COMPATIBLE WITH AN ADVERSE REACTION TO FOREIGN BODY. THIS IS NORMALLY TO BE ASCRIBED TO AN INDIVIDUAL REACTION AND NOT TO A DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN, AFTER ABOUT 3 YEARS FROM THE PRIMARY, AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE REASON FOR THE SURGERY WAS TO EXPLORE WHAT WAS CAUSING THE PAIN. THE ROOT CAUSE OF THE PAIN WAS NOT DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109013 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 150448 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention