BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13963379 · Received March 31, 2022

    Report

    Report Number
    3005180920-2022-00220
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    April 3, 2022
    Report Date
    March 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    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 10 MARCH 2022: LOT 2100262: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2021. EXPIRATION DATE: 2026-APR-12. 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 DEVICE INVOLVED BATCH REVIEW PERFORMED ON 10 MARCH 2022: LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (01.32.3239HCT) LOT 2113118: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-OCT-14. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, 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
    2190029 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 2100262 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention