BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4

    MDR report key: 15400691 · Received September 12, 2022

    Report

    Report Number
    3005180920-2022-00700
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    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 25 AUGUST 2022: LOT 2119453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2022. EXPIRATION DATE: 2027-MAR-20. 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 DEVICES INVOLVED. BATCH REVIEW PERFORMED ON 25 AUGUST 2022: STEM: SMS SOLID 01.36.056 SMS SOLID STEM V2 STD SIZE 1 (K201673) LOT 2013868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2021. EXPIRATION DATE: 2026-MAR-23. 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 CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. ABOUT 20 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805961 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 2119453 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention