BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R

    MDR report key: 12974187 · Received December 10, 2021

    Report

    Report Number
    3005180920-2021-00973
    Event Type
    Injury
    Date Received
    December 10, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862366
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18.NOVEMBER.2021: LOT 2003247: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-07-2020. EXPIRATION DATE: 2025-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0217FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM R (K121416) LOT. 173800. BATCH REVIEW PERFORMED ON 18.NOVEMBER.2021: LOT 173800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-07-2017. EXPIRATION DATE: 2022-07-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 0

    AT 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LOOSE LIGAMENTS THE CAUSE OF THE LOOSE LIGAMENTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872712 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0022R 2003247 07630030862366

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention