BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19069665 · Received April 9, 2024

    Report

    Report Number
    3005180920-2024-00196
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 8, 2024
    Report Date
    April 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030819872
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 MARCH 2024. LOT 2339390: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2023. EXPIRATION DATE: 2028-11-04. 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: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT 2309713: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2023. EXPIRATION DATE: 2028-07-03. 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

    AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN 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
    499441 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2339390 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention