BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 18272865 · Received December 6, 2023

    Report

    Report Number
    3005180920-2023-00940
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 7, 2023
    Report Date
    December 6, 2023
    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 · 0

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2023: LOT 1907359: (B)(4) MANUFACTURED AND RELEASED ON 08-JAN-2020. EXPIRATION DATE: 2024-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER COMPONENTS INVOLVED: LINER: MPACT 01.32.3641HC4 OFFSET 4MM PE HC LINER Ø36/D (K183582) LOT 1810834: (B)(4) MANUFACTURED AND RELEASED ON 04-MAR-2019. EXPIRATION DATE: 2024-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 2 SIMILAR REPORTED EVENTS IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION DUE TO HIP LUXATION AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND A HALF POST PRIMARY SURGERY THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161413 BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 1907359 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention