BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 3 RIGHT

    MDR report key: 5812207 · Received July 21, 2016

    Report

    Report Number
    3005180920-2016-00371
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 23, 2016
    Report Date
    July 21, 2016
    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

    ADDITIONAL INFORMATION RECEIVED ON 05JUL2016 AND INCLUDES: THE PATHOGEN RESULTS ARE NOT AVAILABLE. BATCH REVIEWS PERFORMED ON 18 JULY 2016. LOT 134197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 RIGHT, CODE 02.07.1202R, LOT. 123738 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 NOVEMBER 2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/10MM, CODE 02.07.0210PSF, LOT. 114658 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 FEBRUARY 2012. EXPIRATION DATE: 2017-01-31. 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. GMK-PRIMARY PATELLA RESURFACING SIZE 2, CODE 02.07.0034RP, LOT. 135584 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JANUARY 2014. EXPIRATION DATE: 2018-11-30. 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. ON 19 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT.: NO DEVICE RELATED ROOT CAUSE HAS BEEN IDENTIFIED ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL PRIMARY IMPLANTS AND INPUT A CEMENT ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465414 GMK-PRIMARY FEMUR PS CEMENTED SIZE 3 RIGHT KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 134197

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention