BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS

    MDR report key: 16655503 · Received March 31, 2023

    Report

    Report Number
    3005180920-2023-00230
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    March 4, 2023
    Report Date
    March 31, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261365
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-MAR-2023: LOT 2218606: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2022. EXPIRATION DATE: 2027-09-11. 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. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 30-MAR-2023: GMK-SPHERE 02.12.0723R FEMORAL COMPONENT SPHERE TINBN COATED SIYE 3+ R (K202684) LOT 2112066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2022. EXPIRATION DATE: 2026-12-19. 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. GMK-SPHERE 02.07.2802R FIXED TIBIAL TRAY SIZE 2 R - TINBN COATING (K202684) LOT 2203196: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2022. EXPIRATION DATE: 2027-08-17. 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) 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, 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
    581114 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.E0212FR 2218606 07630971261365

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention