BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 8826043 · Received July 25, 2019

    Report

    Report Number
    3005180920-2019-00604
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 JULY 2019: LOT 181881: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 05-10-2023. 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. ADDITIONAL DEVICES INVOLVED: GMK-SPHERE 02.12.0411FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R (K140826) LOT 183058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JUL-2018. EXPIRATION DATE: 18-06-2023. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF TIGHTNESS IN BOTH HIS LEFT AND RIGHT KNEES. THE SURGEON PERFORMED A BILATERAL POLY SWAP AND RELEASED SCAR TISSUE IN BOTH KNEES. THE SURGEON REVISED THE RIGHT KNEE FROM AN 11MM POLY TO A 10MM POLY AND REVISED THE LEFT KNEE FROM A 10MM POLY TO A 10MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620029 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L 07630030826535 JWH MEDACTA INTERNATIONAL SA 181881 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention