BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/C

    MDR report key: 11087666 · Received December 29, 2020

    Report

    Report Number
    3005180920-2020-00961
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    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 14 DECEMBER 2020: LOT 2000177: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2020. EXPIRATION DATE: 2025-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 (K112115) LOT. 174708. BATCH REVIEW PERFORMED ON 14 DECEMBER 2020: LOT 174708: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-OCT-2017. EXPIRATION DATE: 2022-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 2 MONTHS FROM THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553320 LINER: MPACT FLAT PE HC LINER 32/C ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 2000177

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention