BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

    MDR report key: 14560052 · Received June 1, 2022

    Report

    Report Number
    3005180920-2022-00408
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    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 6 MAY 2022. LOT 2113856: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2022. EXPIRATION DATE: 2026-DEC-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 6 MAY 2022. LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT 2116153: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-DEC-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. AT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933560 MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.202 2113856 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention