BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 8527542 · Received April 18, 2019

    Report

    Report Number
    3005180920-2019-00289
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 20, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 18TH 2019 WE HAVE RECEIVED THE FOLLOWING INFORMATION: DATE OF THE REVISION SURGERY (B)(6) 2019. IF THE REVISION WAS SUCCESSFUL: YES. IF THERE ARE ANY ADDITIONAL INFORMATION REGARDING THE REVISION OR SURGEON'S COMMENT: THE SURGEON DIDN'T COMMENT ABOUT THE EVENT. WE HAVE ALSO RECEIVED POST-OPERATIVE X-RAYS THAT WERE CHECKED BY THE MEDICAL AFFAIRS DIRECTOR REPORTING THAT NO NEW ADDITIONAL SUPPOSITION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: TIBIAL COMPONENT MOBILIZATION 3 YEARS AFTER TOTAL KNEE ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF POSTERIOR SUBSIDENCE OF THE TIBIAL BASEPLATE. POSTOPERATIVE CORTICAL COVERAGE CANNOT BE ASSESSED ON THE BASIS OF INFORMATION RECEIVED. IF FURTHER INFORMATION IS MADE AVAILABLE AFTER THE PLANNED REVISION SURGERY WE MAY BE ABLE TO MAKE A BETTER ASSESSMENT. BATCH REVIEW PERFORMED ON 16 APRIL 2019: LOT 152352: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2015. EXPIRATION DATE: 2020-05-31. 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.

    Description of Event or Problem · 1

    LOOSENING OF THE TIBIAL BASE WITH SLIGHT POSTERIOR DEPRESSION. THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2019 (3 YEARS AND 2 MONTHS FORM THE PRIMARY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319493 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 152352 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention