BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 32 SIZE M 0

    MDR report key: 6529607 · Received April 28, 2017

    Report

    Report Number
    3005180920-2017-00221
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 28, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 13 APRIL 2017 AND INCLUDES: THE PATHOGEN IS NOT AVAILABLE. BATCH REVIEWS PERFORMED ON 24 APRIL 2017. LOT 161450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 APRIL 2016. EXPIRATION DATE: 2021-03-22. 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. MPACT FLAT PE HC LINER Ø32/D, CODE 01.32.3241HCT, LOT. 165674 (K103721), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 OCTOBER 2016. EXPIRATION DATE: 2021-10-06. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312012 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 161450

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention