BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15860118 · Received November 24, 2022

    Report

    Report Number
    3005180920-2022-00890
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    November 10, 2022
    Report Date
    November 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731256
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 NOVEMBER 2022: LOT 2111834: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2021. EXPIRATION DATE: 2026-10-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 15 NOVEMBER 2022 ON BALL HEADS: MECTACER 01.29.214 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L + 4 (K112115) LOT. 2107508 LOT 2107508: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEPT-2021. EXPIRATION DATE: 2026-09-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. AT ABOUT 6 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896671 LINER: MPACT OFFSET 4MM PE HC LINER Ø40/F HIP POLYETHYLENE HIGH-CROSS LINER LPH MEDACTA INTERNATIONAL SA 01.32.4048HC4 2111834 07630040731256

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention