BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

    MDR report key: 7706402 · Received July 20, 2018

    Report

    Report Number
    3005180920-2018-00531
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    June 22, 2018
    Report Date
    July 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827167
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JULY 2018: LOT 153123: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2015. EXPIRATION DATE: 30.04.2020 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. OTHER DEVICE INVOLVED: REFERENCE 02.12.0003R (K121416) FEMORAL COMPONENT SPHERE CEMENTED # 3 R LOT. 161657 LOT 161657: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 APRIL 2016. EXPIRATION DATE: 11.04.2021 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 20 JULY 2018: 1,5 YEARS AFTER PRIMARY CEMENTED TKA THE PATIENT NEEDED REVISION. THE RADIOGRAPHS SUPPLIED CLEARLY SHOW THAT THE POSITION OF THE COMPONENTS IS MOST LIKELY THE CAUSE OF THE PROBLEM. THE ALIGNMENT IS NOT ADEQUATE AND THE TIBIAL TRAY DOES NOT COVER PROPERLY THE TIBIAL METAPHYSIS. WE HAVE ONLY ONE SET OF XRAY THEREFORE WE CANNOT TELL IF THIS POSITION IS THE RESULT OF COMPONENT MIGRATION OR IF IT WAS A SURGICAL DECISION. WE HAVE NO DATA REPORTING ANY PARTICULAR SURGICAL STRATEGY. THERE IS NO REASON TO SUSPECT MALFUNCTIONING DEVICES.

    Description of Event or Problem · 1

    DUE TO MALPOSITIONING OF IMPLANTS (PRIMARILY FEMORAL COMPONENT, BUT ALSO TIBIAL COMPONENT), THE PATIENT SUFFERED RESIDUAL PAIN AND NEEDED A REVISION 1 YEAR AND 8 MONTHS AFTER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548883 GMK SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 153123 07630030827167

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention