BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT OFFSET 4MM PE HC LINER 32/E

    MDR report key: 10905396 · Received November 25, 2020

    Report

    Report Number
    3005180920-2020-00822
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040730839
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 6 NOVEMBER 2020. LOT#: 1810833: 50 ITEMS MANUFACTURED, AND RELEASED ON 4-MAR-2019; EXPIRATION DATE: 2024-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT#: 1811832. BATCH REVIEW PERFORMED ON 6 NOVEMBER 2020. LOT#: 1811832: 311 ITEMS MANUFACTURED AND RELEASED ON 2-APR-2019; EXPIRATION DATE: 2024-03-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 303 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 9 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN DUE A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364408 LINER: MPACT OFFSET 4MM PE HC LINER 32/E PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3244HC4 1810833 07630040730839

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention