BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE S

    MDR report key: 10452932 · Received August 26, 2020

    Report

    Report Number
    3005180920-2020-00542
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 25, 2020
    Report Date
    August 26, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809231
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 AUGUST 2020: LOT 1906477: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2019. EXPIRATION DATE: 2024-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 06 AUGUST 2020: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT 1906072: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2019. EXPIRATION DATE: 2024-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING POST-OP RECOVERY, THE PATIENT'S LINER DISLOCATED FROM THE HEAD. THE DAY AFTER PRIMARY SURGERY THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918090 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.212 1906477 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention