BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT OFFSET 4MM PE HC LINER Ø32/C

    MDR report key: 16806261 · Received April 25, 2023

    Report

    Report Number
    3005180920-2023-00290
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    March 30, 2023
    Report Date
    April 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040730754
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-APR-2023 LOT 1810831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 2024-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASES DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 03-APR-2023 STEM: M-VIZION 01.22.411 PROXIMAL BODY Ø20MM L 80MM LAT WITH HOLES (K201471) LOT. 2115468 LOT 2115468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2022. EXPIRATION DATE: 2027-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASES DURING THE PERIOD OF REVIEW. BALL HEADS: COCR 01.25.025 COCR BALL HEAD 12/14 Ø 32 SIZE XXL +10.5 (K072857) LOT. 152726A LOT 152726A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2020. EXPIRATION DATE: 2025-07-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY THIS ITEM OF THE LOT HAS BEEN SOLD DURING THE PERIOD OF REVIEW. FATHER LOT 152726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-SEP-2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CUP: MPACT 01.38.052MH ACETABULAR SHELL Ø52 MULTI-HOLE (K171966) LOT. 2011324 LOT 2011324: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASES DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD COMPETITOR COMPONENTS AND CAME IN ON (B)(6) 2023 FOR REASONS UNKNOWN AND THE SURGEON REVISED THE COMPETITOR CUP AND LINER WITH A MEDACTA CUP AND LINER, WITH THE INTENTION OF REVISING THE STEM AND HEAD A WEEK LATER. ON (B)(6) 2023, THE PATIENT CAME BACK IN AND HAD THE COMPETITOR STEM AND HEAD REVISED WITH A MEDACTA STEM AND HEAD. ON (B)(6) 2023, THE PATIENT WAS REVISED IN ORDER TO PUT MORE ANTEVERSION IN STEM AND AN OFFSET LINER WAS IMPLANTED. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY STEM, HEAD, CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164434 LINER: MPACT OFFSET 4MM PE HC LINER Ø32/C HIP LINER LPH MEDACTA INTERNATIONAL SA 01.32.3239HC4 1810831 07630040730754

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention