BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M 0

    MDR report key: 10913512 · Received November 27, 2020

    Report

    Report Number
    3005180920-2020-00835
    Event Type
    Injury
    Date Received
    November 27, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 (B)(6) 2020. LOT 150457: 107 ITEMS MANUFACTURED AND RELEASED ON 28-APR-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 11 MONTHS AFTER PRIMARY SURGERY, REPORTING INSTABILITY WHICH WAS CAUSED BY A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD M WITH A 36MM COCR HEAD XXL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378290 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M 0 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 150457 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention