BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L

    MDR report key: 17798546 · Received September 22, 2023

    Report

    Report Number
    3005180920-2023-00714
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    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 (B)(6) 2023. LOT 1903002: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 1903450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2019. EXPIRATION DATE: 2024-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 8 MONTHS 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
    117925 BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 1903002 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention