BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED SIZE 6 STD LEFT

    MDR report key: 6803599 · Received August 18, 2017

    Report

    Report Number
    3005180920-2017-00450
    Event Type
    Injury
    Date Received
    August 18, 2017
    Report Date
    August 18, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820250
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION UNDERWENT BY THE PATIENT. HE HAD A PRIMARY SURGERY ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT HAD A POLY SWAP DUE TO INFECTION. THEN, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION FOR A SECOND TIME. BATCH REVIEWS PERFORMED ON 18 AUGUST 2017. LOT 156144: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 FEBRUARY 2016. EXPIRATION DATE: 2021-01-17. 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 TIBIAL TRAY FIXED CEMENTED SIZE 6 LEFT, CODE 02.07.1206L, LOT. 072440/T (K090988) (B)(4) ITEM RELEASED ON 26 JULY 2017. EXPIRATION DATE: 2021-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. GMK-PRIMARY TIBIAL INSERT FIXED SIZE 6 / 10 MM STD, CODE 02.07.0610SF, LOT. 132857 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THIS LOT. GMK-PRIMARY PATELLA RESURFACING SIZE 3, CODE 02.07.0035RP, LOT. 164134 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 OCTOBER 2016. EXPIRATION DATE: 2021-10-06. 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 CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE ON (B)(6) 2017. THE SURGEON IMPLANTED NEW HARDWARE AS PLANNED ON (B)(6) 2017. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585312 GMK-PRIMARY FEMUR CEMENTED SIZE 6 STD LEFT KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 156144 07630030820250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention