BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 8691461 · Received June 12, 2019

    Report

    Report Number
    3005180920-2019-00455
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 JUN 2019: LOT 185988: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 SEPTEMBER 2018. EXPIRATION DATE: 2023-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (COMPLAINT (B)(4)). ANOTHER DEVICE WAS INVOLVED IN THE COMPLAINT: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 LOT 183354 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2018. EXPIRATION DATE: 2023-08-27. 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.

    Description of Event or Problem · 1

    ABOUT 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A DISLOCATION (HEAD FROM LINER). THE SURGEON REVISED THE CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. AN ANTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483825 LINER: MPACT FLAT PE HC LINER Ø36/F HIP PE HC LINER LPH MEDACTA INTERNATIONAL SA 185988 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention