BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5778945 · Received July 8, 2016

    Report

    Report Number
    3005180920-2016-00336
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    June 9, 2016
    Report Date
    July 8, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD A PRIMARY HIP DONE ON (B)(6) 2011. THEN, SHE HAD THE HEAD REVISED (FIRST REVISION SURGERY) ON (B)(6) 2012. THE REASON AND THE PRODUCTS INVOLVED IN THE FIRST REVISION SURGERY ARE UNKNOWN. ON 24 JUNE 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: INFORMATION IS NOT SUFFICIENT TO PROPERLY ANALYZE THIS CASE. APPARENTLY, THE HEAD ONLY HAS BEEN EXCHANGED TWICE IN LESS THAN 4 YEARS IN A CEMENTLESS THA, BUT THE REASONS FOR THESE OPERATIONS ARE NOT SPECIFIED. THE IMAGE OF THE X-RAYS IS RATHER POOR AND COMPONENT POSITIONS CAN HARDLY BE ASSESSED; HOWEVER, THE CUP GIVES THE IMPRESSION OF BEING IN A POSITION SOMEWHAT ODD AND POSSIBLY TOO HORIZONTAL, BUT IT IS NOT POSSIBLE TO SAY IF THIS HAS AN INFLUENCE ON THE REASONS FOR REVISIONS. BONE DENSITY AROUND THE STEM, PARTICULARLY IN PROXIMAL AREAS AND SPECIFICALLY IN GRUEN ZONE 1 SEEMS TO BE VERY LOW AND SOME SIGNS OF POSSIBLE RADIOLUCENCY ARE ALSO VISIBLE IN GRUEN ZONES 6 AND 7. AGAIN, NO CORRELATION WITH THE PROBLEM CAN BE SOUNDLY ESTABLISHED. THERE IS NO SPECIFIC INDICATION THAT LEADS TOWARDS THE SUSPECT OF A DEFICIENT IMPLANT PERFORMANCE. BATCH REVIEW PERFORMED ON 05 JULY 2016. LOT 121563: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JUNE 2012. EXPIRATION DATE: 2017-04-30. 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. ADDITIONAL INFORMATION RECEIVED ON 08 JULY 2016: THE NEW HEAD WAS A CERAMIC OPTION HEAD SIZE 36 L.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433553 COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 121563

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention