BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S

    MDR report key: 8644142 · Received May 27, 2019

    Report

    Report Number
    3005180920-2019-00411
    Event Type
    Injury
    Date Received
    May 27, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809125
    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 27 MAY 2019: LOT 187070: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2018. EXPIRATION DATE: 2023-11-22. 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 IMPLANT INVOLVED: LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265), LOT 188547: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-13. 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

    ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION. HEAD AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437748 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 187070 07630030809125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention