BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 LEFT

    MDR report key: 6310749 · Received February 8, 2017

    Report

    Report Number
    3005180920-2017-00026
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 6, 2017
    Report Date
    April 27, 2017
    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

    ON 20 JANUARY 2017 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TOTAL KNEE REVISION FOR JOINT INSTABILITY IN A (B)(6) WOMAN 6 MONTHS AFTER PRIMARY CEMENTED KNEE ARTHROPLASTY. ACCORDING TO THE REPORT, THE REASON FOR INSTABILITY WAS THE LOOSENING OF MEDIAL COLLATERAL LIGAMENT WHOSE CAUSES ARE NOT KNOWN. IN THIS CASE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. BATCH REVIEWS PERFORMED ON 06 FEBRUARY 2017. LOT 160115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MARCH 2016. EXPIRATION DATE: 2021-03-09. 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 T3-I4 LEFT, CODE 02.12.T3I4L, LOT. 156834 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2016. EXPIRATION DATE: 2021-02-02. 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 4/13 MM LEFT, CODE 02.12.0413FL, LOT. 141419 (K140826) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 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. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 07 APRIL 2017, THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: SCRATCHES AND DENTS CAN BE IDENTIFIED ON THE DISTAL SURFACE OF THE INSERT. SOME SCRATCHES CAN THEN BE SEEN ON THE MIRROR POLISHED ARTICULAR SURFACE OF THE FEMORAL COMPONENT. THEY HAVE BEEN MOST LIKELY CAUSED DURING THE ATTEMPT TO EXPLANT THE IMPLANT. NO RESIDUAL CEMENT CAN BE IDENTIFIED ON THE TIBIA TRAY AND ON THE INTERNAL PART OF THE FEMUR IN CONTACT WITH THE BONE. THIS IS SOMETHING USUAL TO BE NOTED ON THE EXPLANTED COMPONENTS. THERE ARE NO EVIDENCES THAT MAY LEAD US TO SUSPECT THAT THE EVENT WAS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO FEELING UNSTABLE. THE SURGEON DETERMINED THE MCL WAS LOOSENED. THE SURGEON REVISED THE FEMUR, THE TIBIAL BASEPLATE AND THE INSERT AS THE KNEE NEEDED A MORE CONSTRAINED SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95373 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 LEFT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 160115

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention