BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL 52

    MDR report key: 12364560 · Received August 25, 2021

    Report

    Report Number
    3005180920-2021-00685
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860973
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 AUGUST 2021: LOT 1909301: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2020. EXPIRATION DATE: 2025-02-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 03 AUGUST 2021: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT 1909378: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2020. EXPIRATION DATE: 2024-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. STEM: MASTERLOC 01.39.406 CEMENTLESS TI COATED LAT PLUS STEM SIZE 6 (K173267) LOT 182236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2018. EXPIRATION DATE: 2023-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 1903846: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 2024-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN WITHOUT ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY AND AN ANTEVERTED CUP (FOR UNKNOWN REASONS). 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, HEAD, CUP AND LINER AND REPLACED THEM WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261345 MPACT DOUBLE MOBILITY ACETABULAR SHELL 52 HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152MB 1909301 07630030860973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention