BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TIBIAL INSERT UC FIXED #2/12 MM

    MDR report key: 4782522 · Received May 15, 2015

    Report

    Report Number
    3005180920-2015-00098
    Event Type
    Injury
    Date Received
    May 15, 2015
    Report Date
    September 2, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 03 AUGUST 2015 A FINAL REPORT WAS PREPARED WITH THE INFORMATION ALREADY REPORTED INTO THE INITIAL REPORT. ON 26 AUGUST 2015, THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON MAY 12, 2015. LOT 103151: (B)(4) INSERTS MANUFACTURED AND RELEASED ON NOVEMBER 08 2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. LOT 136008: (B)(4) FEMURS MANUFACTURED AND RELEASED ON JANUARY 27, 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. LOT 112082: (B)(4) BASE PLATES MANUFACTURED AND RELEASED ON SEPTEMBER 26, 2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. ON MAY 04 2015 WE GOT THE CONFIRMATION THAT THE ITEMS WILL BE NOT RETURNED BACK. ON MAY 15 2015 THE (B)(4) MADE THE FOLLOWING ANALYSIS: THE IMPLANT LOOKS CORRECTLY POSITIONED, BUT THERE TRACES OF INFLAMMATORY RESPONSE THAT EXTENDED TO BONE SIGNS. THE SUSPECT OF INFECTION IS COMPATIBLE WITH THE AVAILABLE DATA AND THEREFORE IT IS LIKELY TO BE THE ROOT CAUSE FOR THIS FAILURE. UNLESS DIFFERENT INFORMATION IS OBTAINED, I WOULD ASCRIBED THIS TO INFECTION, AS I SEE NO OTHER EVIDENT OR POSSIBLE CAUSES.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318663 GMK TIBIAL INSERT UC FIXED #2/12 MM FIXED UC INSERT JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1