BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2018-00772

    MDR report key: 7951004 · Received October 10, 2018

    Report

    Report Number
    3005180920-2018-00772
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 9, 2018
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 OCTOBER 2018. LOT 174955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 NOVEMBER 2017. EXPIRATION DATE: 2022-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS REVISED DURING THE REVISION [IMPLANTED IN THE FIRST REVISION ((B)(6) 2015)]: GMK-REVISION 02.07.2404R FEMUR REVISION PS #4 R (K102437). LOT. 155130: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 2015. EXPIRATION DATE: 2020-09-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL15065 EXTENSION STEM - FLUTED Ø 15 L 65 (K120790). LOT. 130370: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 MARCH 2013. EXPIRATION DATE: 2018-01-31. 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

    THE PATIENT HAD A REVISION CASE ON (B)(6) 2015 FOR UNKNOWN REASON: ANOTHER COMPANY PRODUCTS WERE REPLACED WITH MEDACTA FEMORAL COMPONENT, EXTENSION STEM AND TIBIAL INSERT. ON (B)(6) 2018, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE INSERT [COMPLAINT (B)(4)]. ON (B)(6) 2018, THE PATIENT CAME IN AGAIN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention