BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L E-CROSS

    MDR report key: 18083935 · Received November 7, 2023

    Report

    Report Number
    3005180920-2023-00859
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262034
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 2 WEEKS FROM PRIMARY IMPLANTATION DUE TO INFECTION. NO ANOMALIES CAN BE NOTED OF THE EXPLANTED COMPONENTS SENT BACK FOR INVESTIGATION. FROM VISUAL INSPECTION THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 OCTOBER 2023: LOT 2243417: (B)(4) MANUFACTURED AND RELEASED ON 24-JAN-2023. EXPIRATION DATE: 2028-01-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4). ADDITIONAL DEVICES INVOLVED IMPLANTED ON (B)(6) 2023 AND EXPLANTED ON (B)(6) 2023. BATCH REVIEWS PERFORMED ON 12 OCTOBER 2023. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT 2237780: (B)(4) MANUFACTURED AND RELEASED ON 27-DEC-2022. EXPIRATION DATE: 2027-12-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4 OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0006L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L (K121416) LOT 2245088: (B)(4) MANUFACTURED AND RELEASED ON 27-DEC-2022. EXPIRATION DATE: 2028-01-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E004RP PATELLA RESURFACING SIZE 4 E-CROSS (K202022) LOT 2238000: (B)(4) MANUFACTURED AND RELEASED ON 09-NOV-2022. EXPIRATION DATE: 2027-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INVESTIGATION PERFORMED ON THE RECEIVED PICTURES ON 31 OCTOBER 2023 BY MEDACTA KNEE R&D PROJECT MANAGER: REVISION SURGERY AFTER 2 WEEKS FROM PRIMARY DUE TO INFECTION ON A PATIENT THAT WAS ALREADY REVISED FOR INFECTION. PICTURES OF THE EXPLANTED COMPONENTS DOESN'T SHOW ANY ANOMALIES. INFECTION IS AN UNDESIRED EVENT IN KNEE REPLACEMENT SURGERIES THAT REQUIRES REVISION OF IMPLANTED COMPONENTS, UNLIKELY CAUSED BY THE HARDWARE ITSELF. FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297906 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2243417 07630971262034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention