BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5

    MDR report key: 5597327 · Received April 22, 2016

    Report

    Report Number
    3005180920-2016-00177
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    March 23, 2016
    Report Date
    July 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 30 MARCH 2016 AND INCLUDES: THE REASON FOR THE REVISION IS BECAUSE THE PATIENT HAD MULTIPLE HIP DISLOCATIONS. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 141734: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2014. EXPIRATION DATE: 2019-06-30. 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.

    Additional Manufacturer Narrative · 1

    ON 21 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 30 JUNE 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON REMOVED THE HEAD AND REPLACED IT WITH ANOTHER HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253905 COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5 BALL HEAD JDI MEDACTA INTERNATIONAL SA 141734

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention