BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/F

    MDR report key: 10641813 · Received October 7, 2020

    Report

    Report Number
    3005180920-2020-00691
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 9, 2020
    Report Date
    October 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2020: LOT 187909: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2018. EXPIRATION DATE: 2023-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE OTHER SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 1903000. BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2020: LOT 1903000: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2019. EXPIRATION DATE: 2024-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 10 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104858 LINER: MPACT FLAT PE HC LINER 36/F ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 187909 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention