BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 LAT

    MDR report key: 5826389 · Received July 27, 2016

    Report

    Report Number
    3005180920-2016-00400
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    July 7, 2016
    Report Date
    July 27, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT, DESCRIBED AS SPORTY PATIENT, HAD THE FIRST REVISION SURGERY ON (B)(6) 2013 DUE TO PAIN. AMISTEM COLLARED HA COATED STEM SIZE 3 STD WAS IMPLANTED. THE PATIENT HAD PAIN AGAIN ((B)(6) 2016). A SECOND REVISION WILL BE PLANNED. ADDITIONAL INFORMATION RECEIVED ON 18 JULY 2016 AND INCLUDES: IT IS NOT SURE IF A REVISION WILL BE PERFORMED; IN CASE IT WILL BE NECESSARY, THE STEM AND THE HEAD WILL BE REVISED, BUT IT IS NOT KNOWN IF THE CUP WILL BE REPLACED, TOO. ON 22 JULY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: REPEATED STEM LOOSENING ON A SPORTY (B)(6) WOMAN. THE COMPONENTS ARE CORRECTLY IMPLANTED AND NO CAUSE CAN BE IDENTIFIED FROM THE AVAILABLE INFORMATION. BATCH REVIEWS PERFORMED ON 22 JULY 2016. LOT 111238: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2011. EXPIRATION DATE: 2016-05-31. 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. AMISTEM COLLARED HA COATED STEM SIZE 3 STD, CODE 01.18.243, LOT. 124661 (K121011) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 DECEMBER 2012. EXPIRATION DATE: 2017-10-31. 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

    REVISION DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478090 AMISTEM H, HA COATED STEM SIZE 2 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 111238

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention