BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3030692 · Received March 22, 2013

    Report

    Report Number
    3005180920-2013-00026
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 3 STD - REF. 01.18.133 / LOT 102667 (60 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. PAIN WAS PROBABLY DUE TO STRESS SHIELDING: THE REDUCTION IN BONE DENSITY AROUND THE STEM (DETECTED THROUGH X-RAYS). FROM THE DATA COLLECTED, THE CAUSE OF THE PROBLEM IS UNK AND WE DO NOT HAVE EVIDENCE THAT THE EVENT IS DEVICE RELATED. A F/U WILL BE SUBMITTED IN CASE OF ADD'L INFO RECEIVED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION HAS BEEN RECEIVED CONCERNING OUTCOMES FOR THE PATIENT NOR ABOUT THE REVISION SURGERY. THE X-RAY WERE CHECKED BY AN EXPERT SURGEON THAT ADDED A FOLLOWING COMMENT: ON THE POSTOP X-RAY WE CAN SEE IRREGULARITY AT THE GREATER TROCH. WITH LITTLE CYSTS. THAT IS AN INDIRECT SIGN FOR CHRONIC TEARS IN THE HIP ABDUCTOR TENDONS. WHEN THERE IS A WEAKNESS OF THE HIP ABDUCTORS, AUTOMATICALLY THERE IS MORE ADDUCTION WHILE WEIGHT BEARING AND A TYPICALLY TRENDELENBURG SIGN. IN SUCH CASES I HAVE SEEN SUCH HYPERTROPHY OF THE MEDIAL CORTEX. MY PERSONAL OPINION IN SUCH A CASE IS TO TAKE AN APPROACH THROUGH THE TEAR (TRANSGLUTEAL) AND TRY REFIXATION OF THE TENDONS AT THE END. THE CASE WAS FINALLY CLOSED WITH THE INFORMATION AVAILABLE AT THAT TIME.

    Description of Event or Problem · 1

    PT HAD MID THIGH PAIN DUE TO DISTAL STRESS SHIELDING ON THE AMISTEM. AFTER TWO MONTHS, THE PT FEELS BETTER. NO REVISION SURGERY PLANNED SO FAR. MEDACTA WAS INFORMED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119576 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA 102667

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other