BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FEMUR CEMENTED PS #5NARROW / LEFT

    MDR report key: 5250527 · Received November 25, 2015

    Report

    Report Number
    3005180920-2015-00287
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    October 22, 2015
    Report Date
    February 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 NOV 2015 IT WAS COMMUNICATED THAT THE RESULTS FOR THE PATHOGEN CAME BACK NEGATIVE. BATCH REVIEW PERFORMED ON 23 NOVEMBER 2015: GMK FEMUR CEMENTED PS #5NARROW / LEFT, CODE 02.07.2215L LOT. 150301: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2015. EXPIRATION DATE: 2020-01-31. 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 TIBIAL TRAY FIXED CEMENTED # 4 R, CODE 02.07.1204L LOT. 150912 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2015. EXPIRATION DATE: 2020-04-30. 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. GMK TIBIAL INSERT PS FIXED # 4/12MM, CODE 02.07.0412PSF LOT. 136094 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2014. EXPIRATION DATE: 2018-12-31. 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 PATELLA RESURFACING # 2, CODE 02.07.0034RP LOT. 151408 (K090988): LOT 151408: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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.

    Additional Manufacturer Narrative · 1

    ON 22 JANUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 25 JANUARY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 PATIENT CAME IN FOR 6 WEEK POST-OPERATIVE CHECK-UP COMPLAINING OF PAIN AND INFLAMMATION. SURGEON TOOK A BLOOD SAMPLE WHICH SHOWED A HIGH LEVEL OF WHITE BLOOD CELLS. ON (B)(6) 2015 THE SURGEON REMOVED ALL COMPONENTS AND PUT IN AN ALL POLY COMPONENTS WITH ANTIBIOTIC CEMENT. THE EXPLANTS WILL NOT BE RETURNED. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780616 GMK PRIMARY FEMUR CEMENTED PS #5NARROW / LEFT FEMORAL CEMENTED COMPONENT JWH MEDACTA INTERNATIONAL SA 150301

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention