BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2019-00192

    MDR report key: 8455411 · Received March 27, 2019

    Report

    Report Number
    3005180920-2019-00192
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 27, 2019
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 MARCH 2019: LOT 131867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUN-2013. EXPIRATION DATE: 2018-05-31. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL DIRECTOR: TWO YEARS AFTER PRIMARY CEMENTED TKA THE TIBIAL INSERT IS REVISED TO A THICKER ONE. THIS IS PROBABLY DUE TO SECONDARY INSTABILITY, NORMALLY RELATED TO PROGRESSION OF DISEASE AND SECONDARY LIGAMENT LAXITY. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY AFTER 2 YEARS AND 1 MONTH DUE TO PAIN (THE CAUSE OF PAIN IS UNKNOWN). THE SURGEON PERFORMED A SYNOVECTOMY AND SWAPPED THE 12MM POLY WITH A 14MM POLY.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention