BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8527546 · Received April 18, 2019

    Report

    Report Number
    3005180920-2019-00301
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809149
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 APRIL 2019: LOT 180529: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-17. 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. OTHER DEVICE INVOLVED IN THE COMPLAINT: LINER: MPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD (K092265) LOT. 179195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2018. EXPIRATION DATE: 2023-03-26. 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

    REVISION SURGERY 26 DAYS AFTER THE PRIMARY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). 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
    319750 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 180529 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention