BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL 48

    MDR report key: 11045450 · Received December 21, 2020

    Report

    Report Number
    3005180920-2020-00954
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 DECEMBER 2020: LOT 182596: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUGUST-2018. EXPIRATION DATE: 2023-07-23. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 10 DECEMBER 2020: LINER: MPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD (K092265) LOT 172720: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUGUST-2017. EXPIRATION DATE: 2022-07-20. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER, 1 YEAR AND 10 MONTHS AFTER THE PRIMARY. THE PATIENT ONLY HAD A MEDACTA CUP AND LINER IMPLANTED DURING THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516184 MPACT DOUBLE MOBILITY ACETABULAR SHELL 48 HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 01.32.148MB 182596 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention