BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #SIZE 5/11 MM R

    MDR report key: 17360881 · Received July 20, 2023

    Report

    Report Number
    3005180920-2023-00524
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 20, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862663
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 JUNE 2023: LOT 1910205: 50 ITEMS MANUFACTURED AND RELEASED ON 02-JAN-2020. EXPIRATION DATE: 2024-DEC-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: A PRIMARY IMPLANT OF GMK SPHERE WAS MADE ON (B)(6) 23. THE X RAY PERFORMED AT THE FIRST MONTH FOLLOW UP ((B)(6) 2023) SHOWED A RADIOLUCENCY THAT COULD REFER TO THE POLYETHYLENE INLAY THAT APPEARED COMPLETELY DISPLACED ANTERIORLY. WE DO NOT HAVE INFORMATION ABOUT THE CLINICAL STATUS OF THE PATIENT. THE ROOT CAUSE OF THE INLAY DISPLACEMENT COULD BE THE INCORRECT ENGAGEMENT DURING THE FIRST SURGERY. THE PATIENT UNDERWENT A NEW SURGERY TO REVISE THE INSERT ((B)(6) 23) AND IT CONCLUDED SUCCESSFULLY. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 22 JUNE 2023: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 2240400 LOT 2240400: 24 ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-JAN-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO INTRA-PROSTHETIC DISLOCATION OF THE LINER FROM THE TIBIAL TRAY. THE SURGEON REPORTED THAT THE LINER WAS NOT PROPERLY ENGAGED DURING THE PRIMARY SURGERY. ONLY LINER REVISED WITH A 10MM LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42662 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #SIZE 5/11 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0511FR 1910205 07630030862663

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention