BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 5 LAT

    MDR report key: 5673085 · Received May 23, 2016

    Report

    Report Number
    3005180920-2016-00240
    Event Type
    Injury
    Date Received
    May 23, 2016
    Date of Event
    April 18, 2016
    Report Date
    August 3, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 22 JULY 2016 T WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY COLLECTED AND SUBMITTED IN THE INITIAL REPORT. ON 25 JULY 2016 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE (B)(6) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: STEM REVISION IN THA LESS THAN TWO YEARS AFTER PRIMARY IN A VERY TALL AND RATHER HEAVY PATIENT. IN THE POSTOPERATIVE IMAGE, THE STEM DOES NOT SEEM TO FILL WELL THE PROXIMAL FEMUR, THE REASONS FOR THIS ARE UNKNOWN. SIGNS OF PROXIMAL LOOSENING ARE VISIBLE IN THE PRE-REVISION X-RAY. ALSO THE SCREW PROTRUDING IN THE ABDOMEN MAY BE AN ADDITIONAL SOURCE OF PAIN, OR IT MAY BE COMPLETELY SILENT AND HARMLESS. THERE IS NO REASON TO SUSPECT THAT THE FEMORAL LOOSENING WAS CAUSED BY A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 20 MAY 2016. LOT 132646: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 AUGUST 2013. EXPIRATION DATE: 2018-06-30. 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 23 MAY 2016 THE R&D PROJECT MANAGER VISUALLY INSPECTED THE RETRIEVED EXPLANT WITH THE FOLLOWING COMMENTS: OBSERVING THE FEMORAL STEM NO PARTICULAR SIGN CAN BE NOTED, EXCEPT ON THE NECK: SUCH SIGNS WERE PROBABLY CAUSED DURING THE REMOVAL PHASE. BONE IS PRESENT IN THE ANTERIOR AND POSTERIOR SURFACE OF THE STEM, MAINLY ON THE DISTAL PART. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME TO THE SURGEON BECAUSE OF PAIN. AFTER TAKEN THE X-RAYS, THE SURGEON SAW THERE WAS LOOSENING OF THE AMISTEM. REVISION OF THE STEM WAS DONE AND IT WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327229 AMISTEM H, HA COATED STEM SIZE 5 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 132646

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention