BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE S

    MDR report key: 10867714 · Received November 19, 2020

    Report

    Report Number
    3005180920-2020-00813
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    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 30 OCTOBER 2020: LOT 1909760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2020. EXPIRATION DATE: 2025-03-12. 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: LINER: MPACT 01.32.3648HCAT HOODED PE HC LINER Ø36/F (K132879) BATCH REVIEW PERFORMED ON 30 OCTOBER 2020. LOT 1910294: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2020. EXPIRATION DATE: 2025-01-06. 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

    THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335378 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE S HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.208 1909760 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention