BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED ISZE 3+ R

    MDR report key: 18376013 · Received December 21, 2023

    Report

    Report Number
    3005180920-2023-01066
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 8, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    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 21 DECEMBER 2023. LOT 147697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2015. EXPIRATION DATE: 2019-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R (K121416) LOT. 147673: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUNE-2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO HYPEREXTENSION OF THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT (10 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287948 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED ISZE 3+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 147697 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention