BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

    MDR report key: 13340923 · Received January 25, 2022

    Report

    Report Number
    3005180920-2022-00033
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    December 27, 2021
    Report Date
    January 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 DECEMBER 2021. LOT 1905067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    DURING THE PRIMARY KNEE SURGERY AND AFTER CEMENTING THE FEMORAL COMPONENT, THE IMPLANT FELL OFF THE FEMUR. THE SURGEON STATED IT WAS UNUSUAL BEHAVIOR FOR THE CEMENT AND IT WAS NOTICED ON 2 FOLLOWING CASES AFTER THIS ONE. THIS CAUSED AN HOUR DELAY IN THE CASE DUE TO THE HARDENED CEMENT HAVING TO BE REMOVED. THE SAME FEMORAL COMPONENT WAS USED TO COMPLETE SUCCESSFULLY THE CASE. THE CEMENT USED WAS NOT A MEDACTA PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564085 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0004R 1905067 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other