BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FEMUR

    MDR report key: 8208010 · Received January 2, 2019

    Report

    Report Number
    3005180920-2018-01047
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    December 3, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON 18 DECEMBER 2018 THE PATIENT MATCHED DEPARTMENT ANALYZED THE CASE: OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. BATCH REVIEWS PERFORMED ON 28 DECEMBER 2018: LOT 142053: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK SPHERE PE TIBIAL INSERT CODE 02.12.0310FL LOT. 141791 (K121416): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2014 . EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK TIBIAL TRAY CODE 02.07.1203L LOT. 142697 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 JULY 2014 . EXPIRATION DATE: 2019-05-31. 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 02 JANUARY 2019 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: REVISION OF PRIMARY TKA AFTER 4.4 YEARS. ACCORDING TO REPORT, THE CAUSE FOR REVISION IS PAIN AND INSTABILITY. THE LOW-QUALITY XRAYS DO NOT ALLOW ANY FURTHER ANALYSIS. SECONDARY INSTABILITY MAY BE DUE TO PROGRESS OF DISEASE OR TO SECONDARY LIGAMENT LAXITY. WE COULD NOT SEE, PROBABLY BECAUSE OF IMAGE QUALITY, RADIOGRAPHIC SIGNS OF MOBILIZATION. NO CONCLUSION CAN BE DRAWN AS TO THE CAUSES OF THIS REINTERVENTION.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO PAIN AND INSTABILITY 4 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY. ALL THE COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358 GMK SPHERE FEMUR CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 142053 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention