BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 STD

    MDR report key: 5267513 · Received December 4, 2015

    Report

    Report Number
    3005180920-2015-00305
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    November 5, 2015
    Report Date
    January 5, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 30 NOV 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: PATIENT ENDOWED WITH VERY THICK CORTICALS IN THE FEMORAL CANAL. REPORTEDLY, HE WENT TO HAVE HEAVY WORKOUT AGAINST SURGEON'S ADVICE: POSSIBLY THIS WAS DONE TOO EARLY AND THE STEM WAS UNABLE TO ACHIEVE INTEGRATION IN THE PROXIML PART, BUT GOT LOCKED DISTALLY ALSO BECAUSE THIS FEMUR IS VERY STRONG. APPARENTLY, THE INTEGRATION TOOK PLACE ONLY DISTALLY WITH GREAT EFFECT, SO MUCH THAT AN EXTENDED TROCHANTERIC OSTEOTOMY HAD TO BE PERFORMED TO REMOVE THE STEM. IT APPEARS THAT WE CAN DEFINE THE ROOT CAUSE FOR THIS EVENT THE EXCESSIVE EARLY LOADS. FROM THE AVAILABLE INFORMATION, THERE IS NO OTHER INDICATION USABLE FOR A CLINICAL EVALUATION. THIS KIND OF COMPLICATION MAY OCCUR IN THA AND I CAN SEE NO PRODUCT ACTION THAT SHOULD BE UNDERTAKEN. BATCH REVIEW PERFORMED ON 04 DECEMBER 2015: LOT 131569: 60 ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 04 DEC 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION HERE ABOVE.

    Additional Manufacturer Narrative · 1

    ON 07 DECEMBER 2015 THE FINAL REPORT WAS APPROVED. ON 10 DECEMBER 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED THE PRIMARY SURGERY ON (B)(6) 2014. HE ADVISED THE PATIENT AGAINST GOING TO THE GYM AND DOING HEAVY WORKOUTS. THE PATIENT WENT AGAINST THE SURGEONS RECOMMENDATION. DOCTOR THEN RECOMMENDED A REVISION SURGERY DUE TO STEM LOOSENING. HE PATIENT ASKED FOR A SECOND OPINION AND WENT TO SEE ANOTHER SURGEON THAT ALSO RECOMMENDED A REVISION SURGERY. THE PATIENT DECIDED TO LET HIM PERFORM THE REVISION SURGERY ON (B)(6) 2015. THE SURGEON FOUND THAT THE STEM HAD POTTED DISTALLY. AFTER 45 MINUTES ATTEMPTING TO REMOVE THE STEM THE SURGEON PERFORMED AN EXTENDED TROCH OSTEOTOMY. THE SURGEON PUT IN ANOTHER STEM, BALL HEAD AND LINER + CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO EXPLANTS AVAILABLE X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796955 AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 131569

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention