BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C, CEMENTED STEM SIZE 4 STD

    MDR report key: 5717262 · Received June 10, 2016

    Report

    Report Number
    3005180920-2016-00276
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 12, 2016
    Report Date
    August 4, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY REPORTED IN THE INITIAL REPORT. ON (B)(6) 2016 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD BEEN ALREADY REVISED ON (B)(6) 2016 (NON-MEDACTA PRODUCTS) DUE STEM-LOOSENING. ADDITIONAL INFORMATION RECEIVED ON 19 MAY 2016 AND INCLUDES: HEAD LUXATED FORM THE LINER. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 152947: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-04-30. 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. ON (B)(6) 2016, CERAMTEC PROVIDED A DOCUMENT REVIEW OF THE PRODUCT INVOLVED IN THE COMPLAINT (BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE XL +7): THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY WILL BE PERFORMED DUE TO LUXATION/DISLOCATION OF THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371092 AMISTEM C, CEMENTED STEM SIZE 4 STD CEMENTED FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 152947

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention