BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 10572820 · Received September 23, 2020

    Report

    Report Number
    3005180920-2020-00623
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 23, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    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 23-SEP-2020: LOT 1907941: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2019. EXPIRATION DATE: 27-OCT-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R (K121416) LOT. 1905123. BATCH REVIEW PERFORMED ON 23-SEP-2020: LOT 1905123: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2019. EXPIRATION DATE: 29-JUN-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE LINER AND FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038616 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0023R 1907941 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention