BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY CEMENTED STD FEMUR SIZE 3 RIGHT

    MDR report key: 5237528 · Received November 19, 2015

    Report

    Report Number
    3005180920-2015-00270
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    October 20, 2015
    Report Date
    November 19, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON OCT, 23RD 2015 WE WERE INFORMED THAT THE SURGEON SUSPECTED INFECTION AND THEY WOULD HAVE NOT BEEN ABLE TO GET A PATHOLOGY RESULT. BATCH REVIEW PERFORMED ON 17 NOVEMBER 2015: GMK-PRIMARY FEMUR STD CEMENTED # 3 R CODE 02.07.2003R LOT. 120949: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MAY 2012. EXPIRATION DATE: 2017-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED CASE GMK-PRIMARY TIBIAL INSERT UC FIXED # 4 / 12 MM CODE 02.07.0412FUC LOT. 111406 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOV 2011. EXPIRATION DATE: 2016-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED CASE. GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED # 4 R CODE 02.07.1204R LOT. 130427 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 APR 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED CASE. GMK-PRIMARY PATELLA RESURFACING # 2 CODE 02.07.0034RP LOT. 125607 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 FEB 2013. EXPIRATION DATE: 2018-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED CASE. ON 19 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ABOVE REPORTED. ON THE SAME DATE IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Description of Event or Problem · 1

    PATIENT WAS COMPLAINING OF PAIN AND SWELLING OF THE RIGHT KNEE. THE SURGEON REMOVED ALL MEDACTA PRODUCTS AND PUT IN ANTIBIOTIC SPACERS. EXPLANTS WILL NOT BE RETURNED. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766117 GMK PRIMARY CEMENTED STD FEMUR SIZE 3 RIGHT CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 120949

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention