BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS STEM SIZE 7 LAT

    MDR report key: 5370004 · Received January 15, 2016

    Report

    Report Number
    3005180920-2015-00387
    Event Type
    Injury
    Date Received
    January 15, 2016
    Date of Event
    December 16, 2015
    Report Date
    April 14, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON (B)(6) 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 01 JAN 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THE QUALITY OF THE ONE IMAGE SUPPLIED DOES NOT ALLOW A FULL EVALUATION. IT IS NOT KNOWN WHAT POSITION THE PATIENT WAS KEEPING WHEN THE FLUOROSCOPY WAS TAKEN; HOWEVER, IT IS QUITE EVIDENT THAT THE PROXIMALE PART OF THE STEM GOT LOOSE IN GRUEN ZONES 1, 2, 6 AND 7; THERE IS NO IMAGE FOR THE DISTAL PART OF TE SHAFT. THE CUP APPEARS TO BE IN A VERY PECULIAR ORIENTATION, THAT MAY BE AN OBSTACLE FOR FULL RANGE OF MOTION AND CONTRIBUTE TO ABNORMAL STRESSES ON CUP AND STEM FOR POSSIBLE IMPINGEMENT: AS THE PELVIS IS NOT REPRESENTED FULLY WE CANNOT EVALUATE THE REASONS THAT MAY HAVE DIRECTED THE SURGEON TO THIS POSITIONING CHOICE. THE ROOT CAUSE FOR THIS REVISION IS ASEPTIC LOOSENING AND FURTHER CONCLUSION IS NOT POSSIBLE AT THIS STAGE. BATCH REVIEW PERFORMED ON 15 JANUARY 2016: LOT 102341: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 SEPTEMBER 2010. EXPIRATION DATE: 2015-08-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN WHEN GOING FROM A SEATED POSITION TO A STANDING POSITION. THE SURGEON TOOK AN X-RAY AND NOTICED THAT THE STEM WAS LOOSE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRE-OPERATIVE X-RAY IS AVAILABLE. THE EXPLANTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28473 QUADRA-H CEMENTLESS STEM SIZE 7 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 102360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention