BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD 32 SIZE M

    MDR report key: 4173745 · Received August 19, 2014

    Report

    Report Number
    3006639916-2014-00109
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: COCR FEMORAL HEAD SIZE 32 M: REF. 01.25.022 / LOT 133981 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. AMISTEM CEMENTED FEMORAL STEM SIZE 6 LAT REF. 01.18.106 / LOT 134181 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED ABOUT THE DEVELOPMENT OF AN INFECTION IN THE HOSP. ON (B)(6), IT WAS DISCOVERED THAT THE INFECTED PERSON WAS THE PT WHO HAD REVISION SURGERY ON (B)(6), (B)(4). THE PT HAD ANOTHER SURGERY TO WASH THE INFECTED AREA ON (B)(6), THE PATHOGEN WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499803 COCR FEMORAL HEAD 32 SIZE M FEMORAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 133981

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention AMISTEM C LAT CEMENTED STEM SIZE 6 (K103189):| CODE 01.18.106 - LOT 134181