BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 STD

    MDR report key: 6193844 · Received December 21, 2016

    Report

    Report Number
    3005180920-2016-00673
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 21, 2016
    Report Date
    April 27, 2017
    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 24 APRIL 2017, THE R&D PROJECT MANAGER PERFORMED THE VISUAL INSPECTION OF THE RETRIEVED EXPLANTS AND COMMENTED AS FOLLOWS: THE STEM SHOWED A HA COATING STILL PRESENT IN THE PROXIMAL AREA. SOME EVIDENT SCRATCHES ON THE NECK AND HOLES ON THE TAPER LET PRESUME THAT THE EXTRACTION WAS FORCED AND DIFFICULT. IN ADDITION, BIG EVIDENT GROOVES PRESUMABLY DERIVED FROM MILLING TO HELP THE EXTRACTION WERE PRESENT ON THE LATERAL AREA. THE DM LINER SHOWED ALSO TWO GROOVES IN ITS SURFACE, WHILE THE HEAD WAS WITHOUT ANY PARTICULAR SIGNS. FROM THE RECEIVED PIECES IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 06 DECEMBER 2016 AND INCLUDES: THE SURGERY WAS COMPLETED SUCCESSFULLY ON 06 DECEMBER 2016. ON 19 DECEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: CEMENTLESS THA IN A YOUNG MALE PATIENTS WITH VERY NARROW FEMORAL CANAL. AT 2 YEARS, THE STEM HAS FOUND DISTAL FIXATION AND STARTED MOBILIZING PROXIMALLY, WITH RADIOGRAPHIC LOOSENING SIGNS. THIS IS A POSSIBLE ADVERSE EVENT FOLLOWING THA, PARTICULARLY IN YOUNGER PATIENTS WITH SUCH MORPHOTYPES. THE IMPLANT POSITIONING APPEARS CORRECT, THE POSSIBLE SLIGHT LEG LENGTH DISCREPANCY SHOULD NOT BE CONSIDERED RESPONSIBLE FOR THE SUBOPTIMAL OUTCOME. THERE ARE NO INDICATIONS THAT A DEFECT IN THE DEVICE HAS ORIGINATED THIS PROBLEM. BATCH REVIEW PERFORMED ON 21 DECEMBER 2016. LOT 143634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 JULY 2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER STATED THE EXPLANT WOULD HAVE BEEN AVAILABLE FOR FURTHER INVESTIGATIONS (REPORTED IN THE INITIAL REPORT, MDR 2016-00673 SENT TO FDA ON 21 DECEMBER 2016). TO DATE AND AFTER SEVERAL ATTEMPTS, MEDACTA INTERNATIONAL HAS NOT RECEIVED ANY EXPLANT RELATED TO THIS EVENT, YET. ON 17 FEBRUARY 2017 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 06 MARCH 2017 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. DEVICE NOT RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM HAD POTTED. THE SURGEON PLANS TO REVISE THE STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844541 AMISTEM H, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 143634

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention