BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 9769294 · Received February 28, 2020

    Report

    Report Number
    3005180920-2020-00097
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    March 15, 2016
    Report Date
    February 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 FEBRUARY 2020: LOT 154445: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2015. EXPIRATION DATE: 2020-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2016. ADDITIONAL DEVICE INOLVED GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) BATCH REVIEW PERFORMED ON 10 FEBRUARY 2020: LOT 152590: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2015. EXPIRATION DATE: 2020-10-18. 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 SINCE 1-1-2016. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: MOBILIZATION OF CEMENTED PRIMARY TKA AND REVISION AT 4 YEARS AFTER SURGERY. ACCORDING TO THE REPORT, THIS PATIENT NEVER DID WELL. PATELLAR AND TIBIAL COMPONENT WERE FOUND COMPLETELY LOOSE. ALTHOUGH THERE ARE NO DEFINITIVE PROOFS, A CEMENTATION PROBLEM SEEMS TO BE A PLAUSIBLE EXPLANATION FOR THIS ADVERSE EVENT. WE HAVE NO REASON TO THINK THAT THE PATELLAR AND TIBIAL COMPONENT WERE DEFECTIVE.

    Description of Event or Problem · 1

    3 YEARS AND 10 MONTHS AFTER PRIMARY REVISION SURGERY PERFORMED DUE TO TIBIAL COMPONENT AND PATELLA IMPLANT MOBILIZATION. THE TIBIAL AND FEMUR COMPONENTS, PATELLA AND INSERT WERE REVISED. NO INFECTION PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231989 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE TIBIAL IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.1205L 154445 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention