BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12126585 · Received July 7, 2021

    Report

    Report Number
    3005180920-2021-00553
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    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 22 JUNE 2021: LOT 1907336: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-JAN-2020. EXPIRATION DATE: 2024-12-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 22 JUNE 2021: LINER: VERSAFITCUP DM 01.26.2858MHC DOUBLE MOBILITY HC LINER Ø 58/28 (K092265) LOT 1908432: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2019. EXPIRATION DATE: 2024-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    9 MONTHS 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 POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026333 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.202 1907336 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention