BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT OFFSET 4MM PE HC LINER Ø40/G

    MDR report key: 17254958 · Received July 5, 2023

    Report

    Report Number
    3005180920-2023-00487
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 JUNE 2023: LOT 1911130: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2020. EXPIRATION DATE: 2025-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOVLED IN THE EVENT, BATCH REVIEW PERFORMED ON 12 JUNE 2023: BALL HEADS: MECTACER 01.29.243A SLEEVE SIZE XL (K131518) LOT. 19C0075. LOT 19C0075: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.233H HEAD BIOLOX OPTION Ø 40 (K131518) LOT. 19C0070. LOT 19C0070: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6)2023. ON (B)(6)2023, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY (EMDR 2023-00427). PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER, HEAD, AND SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990392 LINER: MPACT OFFSET 4MM PE HC LINER Ø40/G HIP PE LINER LPH MEDACTA INTERNATIONAL SA 01.32.4052HC4 1911130

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention