BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S

    MDR report key: 8495628 · Received April 9, 2019

    Report

    Report Number
    3005180920-2019-00249
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    March 10, 2019
    Report Date
    April 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809231
    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 08 APRIL 2019: LOT 173300: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2017. EXPIRATION DATE: 2022-10-25. 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. ADDITIONAL DEVICE INVOLVED IN THE COMPLAINT: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT 187911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2018. EXPIRATION DATE: 2023-11-11. 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.

    Description of Event or Problem · 1

    REVISION SURGERY ABOUT 1 MONTH AFTER PRIMARY FOR HIP INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE BALL HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290537 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 173300 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention