BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L

    MDR report key: 12720053 · Received October 29, 2021

    Report

    Report Number
    3005180920-2021-00835
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826375
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 2010591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2020. EXPIRATION DATE: 2025-11-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 2005743: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-SEP-2020. EXPIRATION DATE: 2025-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT (KNEE INSTABILITY).

    Description of Event or Problem · 0

    ON (B)(6) 2021, AT 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON IMPLANTED THICKED LINER DUE TO THE PATIENT HAD SOME INSTABILITY TOO. SUBSEQUENTLY, ON (B)(6) 2021, THE PATIENT HAD ANOTHER LINER REVISION DUE TO INFECTION AND INSTABILITY. THE LINER WAS UPSIZED SUCCESSFULLY. IN BOTH CASES THE PATHOGEN IS UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2021, AT 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. SUBSEQUENTLY, ON (B)(6) 2021, THE PATIENT HAD ANOTHER LINER REVISION DUE TO INFECTION AND INSTABILITY. THE LINER WAS UPSIZED SUCCESSFULLY. IN BOTH CASES THE PATHOGEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621144 GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L TIBIAL INSERT FIXED FLEX JWH MEDACTA INTERNATIONAL SA 02.12.0312FL 2010591 07630030826375

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O