BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

    MDR report key: 11831975 · Received May 17, 2021

    Report

    Report Number
    3005180920-2021-00397
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826146
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 APRIL 2021: LOT 160153: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2016. EXPIRATION DATE: 2021-04-21. 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 1-1-2017.

    Description of Event or Problem · 1

    1 YEAR AND 1 MONTH THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND X-RAYS INDICATED THAT THE SCREW FROM THE POLY HAD LOOSENED. THE CAUSE OF THE LOOSENING OF THE SCREW IS UNKNOWN. THE SURGEON REMOVED THE SCREW AND DID NOT REVISE ANY IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733579 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0210FR 160153 07630030826146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention