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: 20088915 · Received August 28, 2024

    Report

    Report Number
    3005180920-2024-00683
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 28, 2024
    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 · 0

    BATCH REVIEW PERFORMED ON 21-AUG-2024. LOT 2345143: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2023. EXPIRATION DATE: 2028-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT 2337439: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2023. EXPIRATION DATE: 2028-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAS BEEN REVISED BECAUSE OF A JOINT LUXATION OCCURRED IN POST-OP RECOVERY, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD, STEM AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191732 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2345143 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention