BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R

    MDR report key: 7826844 · Received August 29, 2018

    Report

    Report Number
    3005180920-2018-00636
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 6, 2018
    Report Date
    August 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862427
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 AUGUST 2018. GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R LOT 166005: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 DECEMBER 2016. EXPIRATION DATE: 2021-11-30. 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. OTHER DEVICE INVOLVED: TIBIAL INSERT FIXED SPHERE FLEX SIZE/10 MM R. LOT 166526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 DECEMBER 2016. EXPIRATION DATE: 2021-11-17. 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.

    Description of Event or Problem · 1

    WE WERE INFORMED ON (B)(6) 2018 THAT THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN AND SLIGHT INSTABILITY. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2018. UPDATE (B)(6) 2018: THE SURGEON REVISED THE LINER AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668313 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 166005 07630030862427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention