BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/10 MM L

    MDR report key: 11300311 · Received February 9, 2021

    Report

    Report Number
    3005180920-2021-00100
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 12, 2021
    Report Date
    February 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826139
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JANUARY 2021: LOT 153531: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2015. EXPIRATION DATE: 2020-10-03. 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 SINECE 2017. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: 5 YEARS AFTER PRIMARY CEMENTED TOTAL KNEE ARTHROPLASTY, THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED AND TIBIAL COMPONENT WAS REVISED. NO CONSEQUENCE SHOULD BE EXPECTED IN CASE OF NO DAMAGE OF THE FEMORAL ARTICULAR SURFACE. THE CAUSE FOR SELF-UNSCREWING OF THE INSERT SCREW IS NOT KNOWN: ONE POSSIBILITY IS INSUFFICIENT TIGHTENING TORQUE, BUT OTHER UNKNOWN CONDITIONS MAY ALSO PLAY A ROLE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 4 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO INLAY LOCKING SCREW UNSCREWING THAT CAUSED PAIN. THE PATIENT HAD A PRIMARY KNEE ON (B)(6) 2016. THE INLAY AND TIBIA WERE REMOVED TO LOCATE THE SCREW AND REMOVE IT, HOWEVER THE SCREW COULD NOT BE LOCATED, IT WAS NOT REMOVED. THE SCREW WAS UNABLE TO BE REACHED EVEN USING X-RAY AS IT WAS RIGHT OUT THE BACK OF THE KNEE WHERE SOME LARGE BLOOD VESSELS ARE AND COULD NOT BE RETRIEVED. IT IS UNKNOWN IF ANY SURGERY WILL BE PERFORMED IN THE FUTURE AND THE PAIN LEVEL OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198990 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0210FL 153531 07630030826139

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention