BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE1/10 MM R

    MDR report key: 8408118 · Received March 11, 2019

    Report

    Report Number
    3005180920-2019-00138
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 9, 2019
    Report Date
    April 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825941
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INFORMATION RECEIVED ON (B)(6) 2020: ON (B)(6) 2020, THE PATIENT CAME IN AND IS HAVING THE ANTIBIOTIC SPACER EXPLANTED AND IS HAVING NEW HARDWARE IMPLANTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MARCH 2019. LOT 123205: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2012. EXPIRATION DATE: 2017-09-30. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: 4 YEARS AND 9 MONTHS AFTER PRIMARY TKR THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED IN AN OPEN REVISION SURGERY THAT ALSO ALLOWED ARTICULAR SURFACE INSPECTION. NO CONSEQUENCE SHOULD BE EXPECTED FOR THE ABSENCE OF THE SCREW IN THE FUTURE LIFE OF THE IMPLANT. 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 DUE TO INLAY LOCKING SCREW UNSCREWING 4 YEARS AND 9 MONTHS AFTER PRIMARY. THE INLAY HAS BEEN CHANGED AND THE SCREW WAS NOT USED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200727 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE1/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0110FR 123205 07630030825941

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention