BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 4

    MDR report key: 9768502 · Received February 28, 2020

    Report

    Report Number
    3005180920-2020-00104
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 FEBRUARY 2020: LOT 160955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2016. EXPIRATION DATE: 2021-04-21. 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

    THE PATIENT HAD A PRIMARY KNEE SURGERY IN 2014, AND WAS IMPLANTED WITH COMPETITOR COMPONENTS. ON (B)(6) 2016, THE PATIENT CAME IN TO HAVE THE COMPETITOR PRODUCTS REVISED. THE SURGEON REVISED THE PATIENT WITH MEDACTA COMPONENTS. PRESENTLY, 3 YEARS AND 6 MONTHS AFTER PRIMARY SURGERY, IT HAS BEEN MADE AWARE THAT THE PATIENT IS IN NEED OF A REVISION DUE TO PARTIAL DISLOCATION OF THE PATELLA. THE CAUSE OF THIS IS UNKNOWN. A REVISION SURGERY HAS NOT BEEN SCHEDULED YET. MORE DETAILS TO FOLLOW WHEN INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233627 GMK-SPHERE PATELLA RESURFACING SIZE 4 PATELLA RESURFACING JWH MEDACTA INTERNATIONAL SA 02.07.0036RP 160955 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 Other