BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    MDR report key: 12266819 · Received August 3, 2021

    Report

    Report Number
    3005180920-2021-00653
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 16, 2021
    Report Date
    March 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 9 NOVEMBER 2021: THE PATIENT HAD CONTINUED TO PRESENT AN INFECTION. THE SURGEON REMOVED THE SPACER, PERFORMED A WASHOUT, AND IMPLANTED ANOTHER ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: ON (B)(6) 2022 THE PATIENT CAME INTO THE HOSPITAL. SPACER WAS REMOVED AND PERMANENT HARWARE WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 JULY 2021. LOT 2010601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2020. EXPIRATION DATE: 2025-10-15. 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 DEVICES INVOLVED: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING # 2 (K090988) LOT. 2011089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MARCH-2021. EXPIRATION DATE: 2025-11-08. 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 02.07.1205L TIBIAL TRAY FIXED CEMENTED # 5 L (K090988) LOT. 2005695: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2020. EXPIRATION DATE: 2025-10-07. 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 02.12.0006L FEMORAL COMPONENT SPHERE CEMENTED # 6 L (K121416) LOT. 2007031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2020. EXPIRATION DATE: 2025-10-07. 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 AN INFECTION (PATHOGEN UNKNOWN). 2 MONTHS AND A HALF AFTER PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167347 GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 2010601 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention