BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 10717883 · Received October 22, 2020

    Report

    Report Number
    3005180920-2020-00730
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815751
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 OCTOBER 2020: LOT 1909670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2019. EXPIRATION DATE: 2024-11-27. 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 IMPLANT INVOLVED: GMK-SPHERE 02.12.0311FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R (K140826) LOT. 1811488. BATCH REVIEW PERFORMED ON 02 OCTOBER 2020: LOT 1811488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2019. EXPIRATION DATE: 2024-03-19. 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 IMPLANT INVOLVED: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 1903511. BATCH REVIEW PERFORMED ON 02 OCTOBER 2020: LOT 1903511: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2019. EXPIRATION DATE: 2024-09-21. 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 IMPLANT INVOLVED: GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT. 1909466. BATCH REVIEW PERFORMED ON 02 OCTOBER 2020: LOT 1909466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2020. EXPIRATION DATE: 2025-02-24. 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, 3 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED A MEDACTA FEMUR AND INSERT TO ACT AS A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182282 GMK-SPHERE PATELLA RESURFACING SIZE 2 PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0034RP 1909670 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention