BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL 52 TWO-HOLES

    MDR report key: 12038956 · Received June 22, 2021

    Report

    Report Number
    3005180920-2021-00513
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 JUNE 2021: LOT 1907399: 174 ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 173 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR EVENTS REPORTED. ADDITIONAL DEVICES INVOLVED LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 1907433: 154 ITEMS MANUFACTURED AND RELEASED ON 01-OCT-2019. EXPIRATION DATE: 2024-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 147 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR REPORTED EVENTS. STEM: AMISTEM P 01.18.401 AMISTEM-P STD STEM SIZE 1 (K173794) LOT 1908256: 150 ITEMS MANUFACTURED AND RELEASED ON 15-GEN-20. EXPIRATION DATE: 2024-12-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 124 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 1908993: 300 ITEMS MANUFACTURED AND RELEASED ON 12-FEB-20. EXPIRATION DATE: 2025-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 295 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    11 MONTHS AFTER THE PRIMARY SURGERY 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935463 MPACT ACETABULAR SHELL 52 TWO-HOLES HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152DH 1907399 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention