BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FEMORAL COMPONENT

    MDR report key: 7142965 · Received December 22, 2017

    Report

    Report Number
    3005180920-2017-00772
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825897
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: ASEPTIC MOBILIZATION OF CEMENTED TKR AFTER LITTLE MORE THAN TWO YEARS. IN A SLIGHTLY VALGUS KNEE PATIENT. THE RADIOGRAPH SHOWS DETACHMENT BETWEEN CEMENT MANTLE AND TIBIAL BONE; ONLY ONE PROJECTION IS AVAILABLE. WITH THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN AS TO THE ROOT CAUSE OF THIS ADVERSE EVENT, BUT THERE IS NO INDICATION OF A FAULTY IMPLANT. BATCH REVIEW PERFORMED ON 22 DECEMBER 2017: LOT 147222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2015; EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL INSERT FIXED FLEX #5/11 MM L REF. (B)(4) LOT. 141422 (K140826): LOT 141422: 74 ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2014; EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK TIBIAL TRAY FIXED CEMENTED # 5 L REF. (B)(4) LOT. 150915 (K090988): LOT 150915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2015; EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE INSERT, TIBIA AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922431 GMK SPHERE FEMORAL COMPONENT CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 147222 07630030825897

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention