BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S

    MDR report key: 15275475 · Received August 23, 2022

    Report

    Report Number
    3005180920-2022-00633
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 24, 2022
    Report Date
    August 23, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809125
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JULY 2022 ON LOT 2100259: LOT 2100259: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2021. EXPIRATION DATE: 2026-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTED COMPONENTS: BATCH REVIEW PERFORMED ON 27 JULY 2022 ON LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28 (K092265) LOT. 2103097: LOT 2103097: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2021. EXPIRATION DATE: 2026-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 10 MOTHS FORM PRIMARY 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
    2901119 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.201 2100259 07630030809125

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention