BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL 56 TWO-HOLES

    MDR report key: 12133588 · Received July 8, 2021

    Report

    Report Number
    3005180920-2021-00560
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810855
    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 24.06.2021: LOT 2006111: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-10-2020. EXPIRATION DATE: 2025-10-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. ADDITIONAL DEVICES INVOLVED: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 2009613: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-10-2020. EXPIRATION DATE: 2025-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. STEM: AMISTEM P 01.18.404 AMISTEM-P STD STEM SIZE 4 (K173794) LOT. 2005307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-09-2020. EXPIRATION DATE: 2025-08-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2007643: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-11-2020. EXPIRATION DATE: 2025-11-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    3 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
    1035459 MPACT ACETABULAR SHELL 56 TWO-HOLES HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 01.32.156DH 2006111 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention