BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L

    MDR report key: 8069024 · Received November 14, 2018

    Report

    Report Number
    3005180920-2018-00906
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825798
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 NOVEMBER 2018: LOT: 171791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 JULY 2017. EXPIRATION DATE: 2022-07-18. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS REVISED: GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L, LOT: 178736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2018. EXPIRATION DATE: 2023-02-20. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED # 2 L, LOT: 177216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 FEBRUARY 2018. EXPIRATION DATE: 2023-02-05. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING # 2, LOT: 176699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 MARCH 2018. EXPIRATION DATE: 2023-02-13. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT HAD COME IN DUE TO SIGNS OF INFECTION AND THE SURGEON HAD REMOVED ALL MEDACTA HARDWARE AT AN UNKNOWN DATE. THE PATHOGEN WAS CONFIRMED AS (B)(6). ON (B)(6) 2018 THE SURGEON REVISED THE SPACER AND IMPLANTED PERMANENT HARDWARE (5 MONTHS AFTER THE PRIMARY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910617 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 L KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 171791 07630030825798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention