BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC

    MDR report key: 10959367 · Received December 7, 2020

    Report

    Report Number
    3005180920-2020-00878
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030806834
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2020: LOT 184721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JULY-2018. EXPIRATION DATE: 2023-07-15. 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 CLINICAL EVALAUTION: HIP DISLOCATION 3 MONTHS AFTER IMPLANTATION OF A DOUBLE MOBILITY IMPLANT IN A CHALLENGING CASE DUE TO PATIENT CLINICAL HISTORY OF A SURGICALLY TREATED INTERTROCHANTERIC FRACTURE. DISLOCATION PROBABLY OCCURRED DURING REHABILITATION. HIP DISLOCATION MAY BE DUE TO COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING; IT CAN HARDLY BE CAUSED BY STANDARD DEVICES. OTHER DEVICE INVOLVED IN THE EVENT: LINER: MPACT 01.32.3844MC DM CONVERTER LINER E/DMC LOT. 1903442 (K131458). BATCH REVIEW PERFORMED ON 20 NOVEMBER 2020: LOT 1903442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2019. EXPIRATION DATE: 2024-10-23. 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

    REVISION SURGERY FOR DISLOCATION OF THE DM POLY LINER FROM THE DM CONVERTER (DM POLY LINER AND COCR HEAD REMAINED COUPLED). THE SURGEON REVISED SUCCESSFULLY THE LINERS AND COCR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422643 LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC DUAL MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2246MHC 184721 07630030806834

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention