BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 RIGHT

    MDR report key: 5772375 · Received July 6, 2016

    Report

    Report Number
    3005180920-2016-00326
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 20 JUNE 2016 AND INCLUDES: THE CAUSE OF PAIN WAS DUE TO THE KNEE BEING TOO TIGHT OR OVER STUFFED. ADDITIONAL INFORMATION RECEIVED ON 22 JUNE 2016 AND INCLUDES: WHEN THE SURGEON REMOVED THE TIBIAL IMPLANT HE FOUND MINIMAL TO NO CEMENT BONDING TO THE UNDER SURFACE OF THE TIBIAL IMPLANT. THE SURGEON IS QUESTIONING WHETHER THE MINIMAL SURFACE FINISH ON THE UNDER SURFACE OF THE TIBIAL TRAY CONTRIBUTES TO POOR CEMENT ADHESION. ON 23 JUNE 2016, THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE PICTURES OF THE TIBIAL BASEPLATE ENCLOSED TO THE COMPLAINT, AND COMMENTED AS FOLLOWS: NO RESIDUAL CEMENT CAN BE SEEN ON THE BOTTOM SURFACE OF THE BASEPLATE IN CONTACT WITH THE BONE. SINCE THE CEMENT IS A FILLER AND NOT AN ADHESIVE, IT IS USUAL TO NOT SEE RESIDUAL CEMENT ON THE EXPLANTED COMPONENT. THE FINISHING OF THE DISTAL SURFACE IS GLASS BEADS BLASTED. FROM THE PICTURES ENCLOSED IT SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED. BATCH REVIEWS PERFORMED ON 05 JULY 2016. LOT 148412: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. 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. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT, CODE 02.07.1203R, LOT. 136131 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MARCH 2014. EXPIRATION DATE: 2019-01-31. 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. GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT, CODE 02.12.0310FR, LOT. 141027 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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. ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT. ON (B)(6) 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE INSERT, THE TIBIAL TRAY AND THE FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426312 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 148412

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention