BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL 60

    MDR report key: 10703209 · Received October 20, 2020

    Report

    Report Number
    3005180920-2020-00729
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030861017
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 OCTOBER 2020: LOT 1810299: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2019. EXPIRATION DATE: 2024-04-15. 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 DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 02 OCTOBER 2020: LINER: VERSAFITCUP DM 01.26.2860MHC DOUBLE MOBILITY HC LINER 28/DML (K092265) LOT 160256: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2016. EXPIRATION DATE: 2021-02-22. 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. STEM: AMISTEM P 01.18.405 AMISTEM-P STD STEM SIZE 5 (K173794) LOT 1910416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2020. EXPIRATION DATE: 2025-04-06. 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. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 1909749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-17. 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, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170666 MPACT DOUBLE MOBILITY ACETABULAR SHELL 60 HIP UNCEMENTED SHELL LPH MEDACTA INTERNATIONAL SA 01.32.160MB 1810299 07630030861017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention