BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED HA COATED STEM SIZE 00 STD

    MDR report key: 6562935 · Received May 12, 2017

    Report

    Report Number
    3005180920-2017-00245
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    April 12, 2017
    Report Date
    May 12, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A BILATERAL HIP. THE RIGHT HIP PRIMARY SURGERY WAS 12 MARCH 2015. THE LEFT HIP PRIMARY WAS 02 APRIL 2015. ON 28 APRIL 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: BILATERAL PARTIAL REVISION IN A FEMALE PATIENT 2 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. BOTH STEMS WERE PLACED IN VARUS POSITION, POSSIBLY DUE TO THE PATIENT'S CHARACTERISTICS BUT PATIENT'S ANATOMY CANNOT BE CLEARLY ASSESSED HAVING ONLY A SINGLE-PROJECTION X-RAY. ALSO, IN THE ONLY PROJECTION AVAILABLE BOTH STEMS LOOK RATHER UNDERSIZED, BUT AGAIN THIS CANNOT BE DECIDED DEFINITELY WITH AP VIEWS ONLY. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT FOLLOWING THA AND CAUSES ARE OFTEN UNDETERMINED. IN THIS CASE, VARUS POSITIONING AND UNDERSIZING MAY HAVE CONTRIBUTED TO THE LOOSENING. A FINAL DETERMINATION OF THE MAIN CAUSE FOR FAILURE CANNOT BE MADE WITH THE AVAILABLE INFORMATION. BATCH REVIEWS PERFORMED ON 08 MAY 2017. LOT 140725: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 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. AMISTEM COLLARED HA COATED STEM SIZE 00 STD, CODE 01.18.229, LOT. 133229 (K121011) LOT 133229: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 SEPTEMBER 2013. EXPIRATION DATE: 2018-08-31. 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. ADDITIONAL INFORMATION RECEIVED ON 11 MAY 2017 AND INCLUDES: THE REVISION IS STILL NOT SCHEDULED YET.

    Description of Event or Problem · 1

    THE PATIENT HAD A BILATERAL HIP IN 2015. APPROX 2 YEARS LATER, THE PATIENT CAME IN COMPLAINING OF PAIN/ INSTABILITY. THE SURGEON DETERMINED THE STEMS ARE LOOSE. THE SURGEON PLANS TO REVISED BOTH HIPS. THE DATE IN WHICH THE REVISION WILL TAKE PLACE IS UNKNOWN AT THIS TIME. X-RAYS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344730 AMISTEM COLLARED HA COATED STEM SIZE 00 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 140725

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention