BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 13001323 · Received December 14, 2021

    Report

    Report Number
    3005180920-2021-01010
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 DECEMBER 2021: LOT 183487: (B)(4). EXPIRATION DATE: 2023-07-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 02 DECEMBER 2021: GMK-SPHERE 02.12.0410CRR TIBIAL INSERT FIXED SPHERE CR #4/10 MM R (K181635) LOT 185620: (B)(4). EXPIRATION DATE: 2023-10-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    AT 3 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND HYPEREXTENSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USED A THICKER LINER TO PROVIDE GREATER VARUS/VALGUS STABILITY AND REVISING THE FEMORAL COMPONENT TO GIVE THE PATIENT A POST TO REDUCE HYPEREXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902521 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R KNEE FEMORAL CEMENTED COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004R 183487 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention