BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/D

    MDR report key: 9206478 · Received October 18, 2019

    Report

    Report Number
    3005180920-2019-00883
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    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 (B)(6) 2019. LOT 1900217: 121 ITEMS MANUFACTURED AND RELEASED ON 12-APR-2019. EXPIRATION DATE: 2024-04-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 69 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2019. BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 1900796 LOT 1900796: 280 ITEMS MANUFACTURED AND RELEASED ON 8-MAY-2019. EXPIRATION DATE: 2024-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 126 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 22 DAYS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND 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
    1002750 LINER: MPACT FLAT PE HC LINER Ø32/D FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 1900217 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention