BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

    MDR report key: 9811230 · Received March 10, 2020

    Report

    Report Number
    3005180920-2020-00151
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 13, 2020
    Report Date
    March 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030861000
    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 26 FEBRUARY 2020: LOT 165910: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JAN-2017. EXPIRATION DATE: 2022-01-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT DM 01.26.2858MHC DOUBLE MOBILITY HC LINER 28/DMI (K092265) LOT. 1905492. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1905492: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEPT-2019. EXPIRATION DATE: 2024-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: STEM: SMS SOLID 01.36.068 SMS SOLID STEM LAT SIZE 8 (K181693) LOT. 182410. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 182410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AGO-2018. EXPIRATION DATE: 2023-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 1905634. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1905634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-AGO-2019. EXPIRATION DATE: 2024-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS (B)(6). 20 DAYS AFTER PRIMARY SURGERY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273182 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58 DOUBLE MOBILITY ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.158MB 165910 07630030861000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention