BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    MDR report key: 16732183 · Received April 13, 2023

    Report

    Report Number
    3005180920-2023-00239
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 14, 2023
    Report Date
    April 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862618
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MARCH 2023. LOT 2100103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON 13 APRIL 2023 ON GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L (K121416) LOT. 2204904. LOT 2204904: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2022. EXPIRATION DATE: 2027-05-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 13 APRIL 2023 ON GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L (K121416) LOT. 2203358. LOT 2203358: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2022. EXPIRATION DATE: 2027-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 POLY AND 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 COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979247 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0413FL 2100103 07630030862618

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention