BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 16679993 · Received April 5, 2023

    Report

    Report Number
    3005180920-2023-00211
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    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 13 MARCH 2023: LOT 2112474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 13 MARCH 2023: GMK-SPHERE 02.12.0025R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R (K140826) LOT 2207547: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2022. EXPIRATION DATE: 2027-06-09. 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. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 2116012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-25. 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 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN, LAXITY AND INSTABILITY IN FLEXION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108905 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 2112474 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention