BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 3D METAL ACETABULAR SHELL Ø50 TWO-HOLE

    MDR report key: 14012351 · Received April 5, 2022

    Report

    Report Number
    3005180920-2022-00233
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 5, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812583
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 MARCH 2022. LOT 2006763: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-OCT-2020. EXPIRATION DATE: 2025-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2009602: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2020. EXPIRATION DATE: 2025-09-23. 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: MASTERLOC 01.39.206 CEMENTLESS TI COATED LAT STEM SIZE 6 (K151531) LOT. 1904515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2019. EXPIRATION DATE: 2024-10-07. 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 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2007631: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2020. EXPIRATION DATE: 2025-11-01. 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 · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94614 CUP: MPACT 3D METAL ACETABULAR SHELL Ø50 TWO-HOLE HIP ACETABULAR CUP CEMENTLESS LPH MEDACTA INTERNATIONAL SA 01.38.050DH 2006763 07630030812583

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention