BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø 36/E

    MDR report key: 5819161 · Received July 25, 2016

    Report

    Report Number
    3005180920-2016-00380
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    June 30, 2016
    Report Date
    July 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 06 JULY 2016 AND INCLUDES: X-RAYS WILL NOT BECOME AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 14 JULY 2016 AND INCLUDES: NO INFECTION WAS FOUND. BATCH REVIEWS PERFORMED ON (B)(6) 2016. LOT 160907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-17. 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. COCR BALL HEAD 12/14 Ø 36 SIZE M 0, CODE (B)(4), LOT. 154625 (K080885); (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 DECEMBER 2015. EXPIRATION DATE: 2020-11-17. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS WILL NOT BE RETURNED TO MEDACTA INTERNATIONAL PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471761 MPACT FLAT PE HC LINER Ø 36/E FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 160907

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention