BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT

    MDR report key: 6710270 · Received July 13, 2017

    Report

    Report Number
    3005180920-2017-00372
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DETAILS: HIGH BMI; BILATERAL SPHERE KNEES. ON 30 JUNE 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TIBIAL LOOSENING IN CEMENTED TKA AFTER 1 YEAR IN A HIGH-BMI FEMALE PATIENT. LOOSENING IS HARDLY DISCERNIBLE FROM THE IMAGES SUPPLIED. NO CAUSE, EXCEPT POSSIBLY THE HIGH BMI, CAN BE IDENTIFIED WITH THE INFORMATION AT HAND. THE PICTURES OF THE IMPLANTS SHOW NO CEMENT BEING ATTACHED TO THE EXPLANTED COMPONENTS; IN SOME CASES THIS MAY BE RELATED TO A CEMENTING TECHNIQUE PROBLEM OR CEMENT FAILURE, BUT IT'S NOT ALWAYS THE CASE. BATCH REVIEW PERFORMED ON 10 JULY 2017. LOT 147905: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. 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 PRIMARY EXTENSION STEM Ø11MM / L 30 MM, CODE 02.07.F11030, LOT. 142842 (K133630) LOT 142842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MAY 2014. EXPIRATION DATE: 2019-03-31. 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. ON 13 JULY 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE IMAGES AND COMMENTED AS FOLLOWS: TIBIAL LOOSENING IN CEMENTED TKA AFTER 1 YEAR IN A HIGH-BMI FEMALE PATIENT. BASED ON THE PICTURES, IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE EVENT, WE CAN ONLY ASSUME THAT HIGH BMI MIGHT HAVE FAVORED THIS LOOSENING. THE PICTURES OF THE IMPLANTS SHOW NO CEMENT BEING ATTACHED TO THE EXPLANTED COMPONENTS; IN SOME CASES THIS MAY BE RELATED TO A CEMENTING TECHNIQUE PROBLEM OR CEMENT FAILURE, BUT IT'S NOT ALWAYS THE CASE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED PAIN AND HAS GONE TO SEE ANOTHER SURGEON. THE BONE SCAN WAS SHOWING ACTIVITY ON BOTH THE TIBIA AND FEMUR APPARENTLY. THE SURGEON PLANNED TO DO PATELLA OR POTENTIALLY REVISE BOTH COMPONENTS. AT REVISION, THE SURGEON FOUND THE FEMUR WAS WELL FIXED BUT FELT THE TIBIA WAS LOOSE. THIS SURGEON WAS NOT FAMILIAR WITH THE GMK-SPHERE PROTHESIS AND DECIDED TO REVISE ALL COMPONENTS. HE ENDED UP IMPLANTING A HINGE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491443 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 147905 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention