BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/G

    MDR report key: 12605472 · Received October 11, 2021

    Report

    Report Number
    3005180920-2021-00805
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    September 17, 2021
    Report Date
    October 11, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    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 20 SEPTEMBER 2021: LOT 2001308: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2020. EXPIRATION DATE: 2025-MAR-15. 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 IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 2004513. BATCH REVIEW PERFORMED ON 20 SEPTEMBER 2021: LOT 2004513: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUNE-2020. EXPIRATION DATE: 2025-MAY-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 · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508921 LINER: MPACT FLAT PE HC LINER 36/G ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3652HCT 2001308 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention