BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C, CEMENTED STEM SIZE 0 STD

    MDR report key: 6300127 · Received February 3, 2017

    Report

    Report Number
    3005180920-2017-00014
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 4, 2017
    Report Date
    April 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 APRIL 2017, THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE AMISTEM C WAS ANALYZED AND NO PARTICULAR AND EVIDENT SIGNS WERE NOTICED, EXCEPT FOR SOME EVIDENT AND SIGNIFICANT SCRATCHES AND SIGNS ON THE NECK SURFACE, MOST PROBABLY OCCURRED DURING THE REVISION OF THE STEM. THE DM LINER WAS IN GOOD CONDITIONS, WHILE THE CERAMIC BALL HEAD SHOWED SOME SIGNS ON THE RIM, DUE TO THE EXTRACTION HITS. FROM THE RECEIVED PIECES IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 JANUARY 2017. LOT 112648: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 AUGUST 2011. EXPIRATION DATE: 2016-06-30. 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. ON 17 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEMORAL STEM MOBILIZATION IN HYBRID THA 1,5 YEARS AFTER PRIMARY OPERATION. ONLY PRE-REVISION X-RAYS ARE AVAILABLE, AND THE STEM LOOKS SIGNIFICANTLY TILTED IN VARUS POSITION. IT IS CONCEIVABLE THAT FOR UNKNOWN REASONS THE STEM HAD A VARUS TILT SINCE THE ORIGINAL TREATMENT, WITH POSSIBLE INTERRUPTION OF CEMENT MANTLE IN DISTAL-LATERAL POSITION, WHICH MAY HAVE CONTRIBUTED TO SECONDARY LOOSENING. WITH THE INFORMATION AVAILABLE, THIS DOES NOT SEEM TO BE A PROBLEM CAUSED BY A FAULTY IMPLANT. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON CONFIRMED THE STEM WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE PATIENT DID NOT EXPERIENCE ANY TRAUMA. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84000 AMISTEM C, CEMENTED STEM SIZE 0 STD CEMENTED FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 112648

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention