BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 LEFT

    MDR report key: 6844647 · Received September 6, 2017

    Report

    Report Number
    3005180920-2017-00489
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 7, 2017
    Report Date
    September 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825859
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD A PRIMARY KNEE ON (B)(6) 2015. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, AND THE SURGEON PERFORMED A POLY SWAP ON (B)(6) 2016. THE PATHOLOGY RESULTS WERE NEGATIVE. IN (B)(6) 2017 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. BATCH REVIEWS PERFORMED ON 04 SEPTEMBER 2017. LOT 146800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2014. EXPIRATION DATE: 2019-09-30. 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-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 LEFT, CODE 02.07.1205L, LOT. 152817 (K090988) (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. GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 MM LEFT, CODE 02.12.0513FL, LOT. 141423 (K140826) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2014. EXPIRATION DATE: 2019-03-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS CONFIRMED AS (B)(6). THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN 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
    625334 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 LEFT KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 146800 07630030825859

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention