BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

    MDR report key: 9870914 · Received March 24, 2020

    Report

    Report Number
    3005180920-2020-00195
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 24, 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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 MARCH 2020: LOT 1904336: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2019. EXPIRATION DATE: 2024-09-28. 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: VERSAFITCUP DM 01.26.2858MHC DOUBLE MOBILITY HC LINER Ø 58/28 (K092265) LOT. 1904373. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 MARCH 2020: LOT 1904373: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2019. EXPIRATION DATE: 2024-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 1903848. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 MARCH 2020: LOT 1903848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 2024-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: STEM: SMS SOLID 01.36.050 SMS SOLID STEM STD SIZE 10 (K181693) LOT. 1905373. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 MARCH 2020: LOT 1905373: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2019. EXPIRATION DATE: 2024-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338334 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58 DOUBLE MOBILITY ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.158MB 1904336 07630030861000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention