BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 40 SIZE M

    MDR report key: 12505848 · Received September 21, 2021

    Report

    Report Number
    3005180920-2021-00761
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    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 26 AUGUST 2021: LOT 2009409: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2021. EXPIRATION DATE: 2026-JAN-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 26 AUGUST 2021: LINER: MPACT 01.32.4052HC4 OFFSET 4MM PE HC LINER Ø40/G (K183582) LOT 2009672: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2020. EXPIRATION DATE: 2025-OCT-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. 23 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407294 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 40 SIZE M CERAMIC ACETABULAR HEAD LZO MEDACTA INTERNATIONAL SA 01.29.213 2009409 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention