BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 15559440 · Received October 7, 2022

    Report

    Report Number
    3005180920-2022-00767
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    September 15, 2022
    Report Date
    November 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-SEP-2022: LOT 2201056: (B)(4). EXPIRATION DATE: 2027-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 21-SEP-2022: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 (K090988) LOT 2114767: (B)(4). EXPIRATION DATE: 2027-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D KNEE PROJECT MANAGER: REVISION SURGERY OF A GMK SPHERE TIBIAL INSERT AFTER ONE WEEK FROM PRIMARY IMPLANTATION DUE TO PAIN. FROM POST-OP X-RAYS, IT WAS DISCOVERED THAT THE TIBIAL INSERT WAS NOT ENGAGED IN THE BASEPLATE AND CAME OFF. THE INSERT LOOKS DAMAGED ON ITS BOTTOM SURFACE, WITH SORT OF INCISIONS OF THE NEGATIVE SHAPE OF THE PERIPHERAL CONTENTIVE PROFILE OF THE BASEPLATE. THIS IS THE EVIDENCE THAT THE INSERT WAS NOT ENGAGED INTO THE BASEPLATE AND WAS JUST LEANING ON TOP OF THE BASEPLATE. MOST LIKELY THE INSERT HAS NEVER BEEN ENGAGED IN THE BASEPLATE. FROM VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AND 3 WEEKS AFTER THE PRIMARY DUE TO PAIN CAUSED BY THE TIBIAL INSERT NOT COMPLETELY ENGAGED INTO THE TIBIAL TRAY. PRE-REVISION X-RAYS CONFIRMED THE DISENGAGEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY BY IMPLANTING A NEW INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855094 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL LINER JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 2201056 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention