BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG

    MDR report key: 17697673 · Received September 7, 2023

    Report

    Report Number
    3005180920-2023-00683
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-AUG-2023. LOT 2302833:(B)(4) MANUFACTURED AND RELEASED ON 17-APR-2023 . EXPIRATION DATE: 2028-04-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 16-AUG-2023 ON CUP: IMPACT 01.32.154MB DOUBLE MOBILITY ACETABULAR SHELL Ø54 (K143453) LOT. 2249164 LOT 2249164: 30ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2023. EXPIRATION DATE: 2028-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ON THE SAME DAY OF THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION OF THE HEAD AND THE LINER FROM THE CUP. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT HAS BEEN REPORTED THAT THE PATIENT KEPT MOVING HIS LEGS AND IT IS SUSPECTED THAT HE INTENTIONALLY DISLOCATED HIS HIP, IN ORDER TO STAY IN THE HOSPITAL LONGER, INSTEAD OF RETURNING TO PRISON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292895 LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG HIP DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 2302833 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention