BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L

    MDR report key: 8815009 · Received July 23, 2019

    Report

    Report Number
    3005180920-2019-00592
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826177
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JULY 2019: LOT 181878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-06-2018. EXPIRATION DATE: 2023-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D KNEE MANAGER: DURING THE PRIMARY KNEE SURGERY AND WHILE ATTEMPTING TO ENGAGE THE INSERT SCREW INTO THE TIBIAL TRAY, THE SURGEON OBSERVED THAT THE SCREW WOULD NOT ENGAGE WITH THE TIBIAL TRAY. THE SURGEON USED ANOTHER 12MM S2 SPHERE INSERT TO COMPLETE THE CASE. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY. THE RETURNED TIBIAL INSERT PRESENTS SOME DENTS AND SCRATCHES ON THE ANTERIOR PART, MOST LIKELY CAUSED DURING THE HANDLING OF THE INSERT IN THE ATTEMPT TO INSERT, FIX AND REMOVE THE INLAY FROM THE JOINT. THE HOLE OF THE SCREW SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED. A FUNCTIONAL TEST HAS BEEN ALSO PERFORMED TO VERIFY THE POSSIBILITY TO ENGAGE THE SCREW INTO THE INSERT. AS RESULT OF THIS TEST, IT WAS POSSIBLE TO ENGAGE THE DEDICATED SCREW AND FIX THE INLAY INTO THE BASEPLATE. FROM VISUAL INSPECTION OF THE RETURNED INSERT, THE ISN'T THE EVIDENCE TO LINK THE EVENT TO A FAULTY DEVICE. CAUSE FOR THE EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    DURING THE PRIMARY KNEE SURGERY AND WHILE ATTEMPTING TO ENGAGE THE INSERT SCREW INTO THE TIBIAL TRAY, THE SURGEON OBSERVED THAT THE SCREW WOULD NOT ENGAGE WITH THE TIBIAL TRAY. THE SURGEON USED ANOTHER 12MM S2 SPHERE INSERT TO COMPLETE THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611681 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 181878 07630030826177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other