BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11562515 · Received March 24, 2021

    Report

    Report Number
    3005180920-2021-00230
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809255
    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 04 MARCH 2021: LOT 2004419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2020. EXPIRATION DATE: 2025-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 04 MARCH 2021: LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641), LOT. 2005019: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2020. EXPIRATION DATE: 2025-09-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD 23 DAYS AFTER THE PRIMARY SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE LINER WAS LEFT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461325 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L CERAMIC FEMORAL BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.214 2004419 07630030809255

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention