BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT HOODED PE HC LINER Ø36/F

    MDR report key: 14019141 · Received April 6, 2022

    Report

    Report Number
    3005180920-2022-00245
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812125
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2003345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JULY-2020. EXPIRATION DATE: 2025-JUN-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITION COMPONENT INVOLVED: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 2109348: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 2 DAYS AFTER THE PRIMARY LEFT HIP SURGERY, THE PATIENT'S HEAD DISLOCATED FROM THE LINER IN PHYSICAL THERAPY. THE SURGEON CONVERTED THE PATIENT TO A DM HEAD AND LINER, REVISED THE STEM, AND REPOSITIONED THE CUP AND ADDED 2 SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338372 LINER: MPACT HOODED PE HC LINER Ø36/F HIP ACETABULAR LINER PE LPH MEDACTA INTERNATIONAL SA 01.32.3648HCAT 2003345 07630030812125

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention