BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK RESURFACING PATELLA SIE 1

    MDR report key: 7074512 · Received December 1, 2017

    Report

    Report Number
    3005180920-2017-00719
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 3, 2017
    Report Date
    December 1, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815737
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 DECEMBER 2017: LOT 156392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 FEBRUARY 2016; EXPIRATION DATE: 2021-02-07. 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 CALLED MEDACTA USA COMPLAINING OF PAIN. THE PATIENT SAW ANOTHER SURGEON WHO BELIEVES THE PATELLA MAY BE LOOSE. THE PATIENT IS DISSATISFIED WITH THE PRIMARY SURGEON. FURTHER INFORMATION WILL NOT BE ACCESSIBLE AS THE INFORMATION CAME DIRECTLY FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855930 GMK RESURFACING PATELLA SIE 1 PE RESURFACING PATELLA JWH MEDACTA INTERNATIONAL SA 156362 07630030815737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other