BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5

    MDR report key: 5697073 · Received June 3, 2016

    Report

    Report Number
    3005180920-2016-00264
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    May 6, 2016
    Report Date
    August 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 31 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 12 AUGUST 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 01 JUNE 2016. LOT 144549: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. 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 Ø 36/F, CODE 01.32.3648HCT, LOT. 140553 (K103721). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2014. EXPIRATION DATE: 2019-02-28. 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 COMPLAINING OF PAIN. THE SURGEON NOTICED THAT THE PATIENT'S HIP WAS DISLOCATED. THE SURGEON REVISED ONLY THE LINER AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351364 COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 144549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention