BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 11568009 · Received March 25, 2021

    Report

    Report Number
    3005180920-2021-00238
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 25, 2021
    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 25 MARCH 2021: LOT 189225: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2019. EXPIRATION DATE: 2023-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L (K140826) LOT. 1901870. BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 1901870: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-24. 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 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 1904219. BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 1904219: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2019. EXPIRATION DATE: 2024-10-02. 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 02.12.0412CRL TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM L (K181635) LOT. 185590. BATCH REVIEW PERFORMED ON 25 MARCH 2021: LOT 185590: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2018. EXPIRATION DATE: 2023-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS WITH COMPETITOR HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466164 GMK-SPHERE PATELLA RESURFACING SIZE 2 PATELLAR IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0034RP 189225 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention