BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø62

    MDR report key: 16874595 · Received May 5, 2023

    Report

    Report Number
    3005180920-2023-00332
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030861024
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-APR-2023. LOT 1909169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2020. EXPIRATION DATE: 2025-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: STEM: MASTERLOC 01.39.210 CEMENTLESS TI COATED LAT STEM SIZE 10 (K151531) LOT. 166787D: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2020. EXPIRATION DATE: 2025-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED CASES DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2862MHC DOUBLE MOBILITY HC LINER Ø 62/28 (K092265) LOT. 2103104: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2021. EXPIRATION DATE: 2026-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT. 1909747: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2020. EXPIRATION DATE: 2025-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL COMPONENTS AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814018 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø62 HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.162MB 1909169 07630030861024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention