BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 9155298 · Received October 4, 2019

    Report

    Report Number
    3005180920-2019-00835
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    September 1, 2019
    Report Date
    October 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16.SEP 2019: LOT 188902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-26. 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. ADDITIONAL IMPLANT INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON 16.SEP 2019: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 1810801. LOT 1810801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2019. EXPIRATION DATE: 2024-02-26. 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

    REVISION SURGERY AFTER 1,5 MONTHS AFTER THE PRIMARY DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948690 LINER: MPACT FLAT PE HC LINER Ø36/F FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 188902 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention