BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50

    MDR report key: 11284520 · Received February 5, 2021

    Report

    Report Number
    3005180920-2021-00084
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    January 7, 2021
    Report Date
    February 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860966
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT AND REPORT SOURCE HAVE BEEN CORRECTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 JANUARY 2021 LOT 1901388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JULY-2019. EXPIRATION DATE: 2024-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 JANUARY 2021 LINER: MPACT DM 01.26.2850MHC DOUBLE MOBILITY HC LINER 28/DME (K092265) LOT. 1901455 LOT 1901455: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. EXPIRATION DATE: 2024-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND ANOTHER SIMILAR EVENT HAS BEEN REPORTED. STEM: AMISTEM-P COLLARED 01.18.433 AMISTEM-P COLLARED STD STEM SIZE 3 (K173794) LOT. 1907017 LOT 1907017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-NOV-2019. EXPIRATION DATE: 2024-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 1908980 SN N/A. LOT 1908980: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2020. EXPIRATION DATE: 2025-01-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND ANOTHER SIMILAR EVENT HAS BEEN REPORTED.

    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 IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER, 5 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180929 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50 DOUBLE MOBILITY ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150MB 1901388 07630030860966

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention