BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 8522872 · Received April 17, 2019

    Report

    Report Number
    3005180920-2019-00296
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 23, 2019
    Report Date
    April 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 APRIL 2019: LOT 186078: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2018. EXPIRATION DATE: 2023-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT ((B)(4)). ADDITIONAL IMPLANT INVOLVED (EVEN IF NOT REVISED): GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R (K121416), LOT 180372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2018. EXPIRATION DATE: 2023-05-06. 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. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988), LOT 184965: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2018. EXPIRATION DATE: 2023-10-11. 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. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988), LOT 187398: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-10-21. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION PERFORMED ON THE NEXT DAY, ABOUT 1 MONTH AFTER PRIMARY, DUE TO INFECTION: THE SURGEON PERFORMED WASHOUT AND SWAPPED THE LINER. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS HOSPITALIZED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315574 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT FLEX JWH MEDACTA INTERNATIONAL SA 186078 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention