BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 00 STD

    MDR report key: 7032796 · Received November 15, 2017

    Report

    Report Number
    3005180920-2017-00658
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803765
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 03 NOVEMBER 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PARTIAL HIP REVISION SURGERY OCCURRED 2 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. IN THE POSTOPERATIVE X-RAY PROVIDED THE STEM LOOKS UNDERSIZED AND IN VARUS POSITION. THE REASON OF THIS CHOICE CANNOT BE DETERMINED: PARTICULAR PATIENT ANATOMY MAY BE THE REASON BUT THIS CANNOT BE ASSESSED HAVING A SINGLE AP PROJECTION. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. BATCH REVIEWS PERFORMED ON 13 NOVEMBER 2017. LOT 170001: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2017. EXPIRATION DATE: 2022-05-11. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4, CODE 01.29.204, LOT. 172254 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2017. EXPIRATION DATE: 2022-07-17. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM HAS SUBSIDED. THE CAUSE IS UNKNOWN. THE SURGEON SWAPPED THE HEAD. THE STEM WAS WELL FIXED AT THIS POINT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812255 AMISTEM H, HA COATED STEM SIZE 00 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 170001 07630030803765

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention