BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C, CEMENTED STEM SIZE 4 STD

    MDR report key: 6151281 · Received December 7, 2016

    Report

    Report Number
    3005180920-2016-00641
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 8, 2016
    Report Date
    December 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 05 DECEMBER 2016. LOT 145439: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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. BIPOLAR HEAD Ø28X55, CODE 25060.2855, LOT. 142878 (K091967) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 JULY 2014. EXPIRATION DATE: 2019-06-30. 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. COCR BALL HEAD 12/14 Ø 28 SIZE M 0, CODE 01.25.012, LOT. 162361 (K072857) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JUNE 2016. EXPIRATION DATE: 2021-05-30. 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. ADDITIONAL INFORMATION RECEIVED ON 06 DECEMBER 2016 AND INCLUDES: TO DATE, THE PATHOGEN RESULT IS UNKNOWN. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL MEDACTA PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803707 AMISTEM C, CEMENTED STEM SIZE 4 STD CEMENTED FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 145439

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention