BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 19850440 · Received July 29, 2024

    Report

    Report Number
    3005180920-2024-00565
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10-JUL-2024: LOT 1903000: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-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 NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 10-JUL-2024: LINER: IMPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 187909: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2018. EXPIRATION DATE: 2023-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 ABOUT 4 YEARS AND 8 MONTHS AFTER 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
    995226 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 1903000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention