BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/D

    MDR report key: 9937100 · Received April 8, 2020

    Report

    Report Number
    3005180920-2020-00234
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 12, 2020
    Report Date
    April 8, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 24 MARCH 2020: LOT 1902883: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-23. 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 IN THE EVENT, BATCH REVIEW PERFORMED ON 24 MARCH 2020: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115). LOT 1904639: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2019. EXPIRATION DATE: 2024-09-10. 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

    THE PATIENT CAME IN 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA 32MM BIOLOX DELTA HEAD S WITH A MEDACTA 32MM BIOLOX OPTION HEAD AND REVISED THE MEDACTA MPACT FLAT LINER HC 32/D WITH A MEDACTA MPACT FLAT LINER HC 32/D. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402017 LINER: MPACT FLAT PE HC LINER Ø32/D LINER FLAT PE HC LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 1902883 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention