BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    MDR report key: 10867712 · Received November 19, 2020

    Report

    Report Number
    3005180920-2020-00820
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862472
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 NOVEMBER 2020: LOT 188195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2018. EXPIRATION DATE: 2023-12-06. 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 DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 03 NOVEMBER 2020: GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT 1902670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2019. EXPIRATION DATE: 2024-07-07. 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. GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX #2/10 MM L (K121416) LOT 1902467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2019. EXPIRATION DATE: 2024-05-21. 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.

    Description of Event or Problem · 1

    PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. WHEN THE PATIENT CAME TO THE HOSPITAL ON (B)(6) 2020, THE SURGEON DISCOVERED THE INFECTION. THE SURGEON ONCE REMOVED THE IMPLANTS FROM THE PATIENT'S BODY AND INSERTED THE CEMENT MOLD SPACER ON (B)(6) 2020. REVISION SURGERY WILL BE PLANNED WITH THE COMPETITOR'S DEVICE AFTER THE FOLLOWING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335380 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.12.0022L 188195 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention