BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L

    MDR report key: 15027950 · Received July 15, 2022

    Report

    Report Number
    3005180920-2022-00526
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 17, 2022
    Report Date
    August 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862601
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24-JUN-2022. LOT 2002798: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2020. EXPIRATION DATE: 2025-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-AUG-2022 . LOT 2001705: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2020. EXPIRATION DATE: 2025-03-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT WITH A THICKER ONE TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED GMK-SPHERE TIBIAL INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A REVISION RIGHT KNEE SURGERY AND PRIMARY LEFT KNEE SURGERY ON (B)(6) 2021 . ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED GMK-SPHERE TIBIAL INSERT - FLEX LEFT - 11 MM S4 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967087 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L KNEE TIBIAL INSERT PE JWH MEDACTA INTERNATIONAL SA 02.12.0417FR 2001705 07630030862601

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention