BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9155299 · Received October 4, 2019

    Report

    Report Number
    3005180920-2019-00846
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2019: LOT 1900804: 299 ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2019. EXPIRATION DATE: 2024-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 178 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2019: LINER: MECTACER 01.29.414 CERAMIC LINER Ø 36 / F LOT. 1810818 (THE ITEN IS NOT REGISTERED IN USA) LOT 1810818: 349 ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2019. EXPIRATION DATE: 2024-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 251 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 1 MONTH FROM THE PRIMARY DUE TO INFECTION(STAPHYLOCCOCUS) OF THE HIP JOINT. THE HEAD AND LINER HAVE BEEN REVISED AND PERFORMED THE WASHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948691 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 1900804 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention