BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R

    MDR report key: 8762568 · Received July 4, 2019

    Report

    Report Number
    3005180920-2019-00531
    Event Type
    Injury
    Date Received
    July 4, 2019
    Date of Event
    June 13, 2019
    Report Date
    September 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862366
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019 WE BECAME AWARE THAT THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY. SURGEON REMOVED THE FEMUR, TIBIA AND INSERT. CAUSE OF PAIN WAS STIFFNESS AND INSUFFICIENT RANGE OF MOTION.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019 WE RECEIVED THE CONFIRMATION OF THE REVISION SURGERY DATE AND OUTCOME.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED SUCCESSFULLY 7 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY.

    Description of Event or Problem · 0

    REVISION SURGERY SCHEDULED FOR (B)(6) 2019, 7 MONTHS AFTER THE PRIMARY DUE TO PAIN AND STIFFNESS AND INSUFFICIENT RANGE OF THE MOTION. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 JUN 2019: LOT 181857: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-05-31. 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 ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 14 JUN 2019: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988), LOT. 187294. LOT 187294: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2018. EXPIRATION DATE: 2023-09-05. 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 02.12.0210FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R (K121416), LOT. 181893. LOT 181893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 2023-05-10. 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

    7 MONTHS AFTER THE PRIMARY THE PATIENT HAD KNEE PAIN AND STIFFNESS. REVISION SURGERY WAS PLANNED ON (B)(6) 2019, WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION ABOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556294 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 181857 07630030862366

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention