BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM

    MDR report key: 9393610 · Received December 2, 2019

    Report

    Report Number
    3005180920-2019-00999
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817267
    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 11-NOV-2019: LOT 140222: 30 ITEMS MANUFACTURED AND RELEASED ON 08-APR-2014. EXPIRATION DATE: 28/02/2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 11-NOV-2019: GMK-PRIMARY 02.07.0317PSF TIBIAL INSERT PS FIXED SIZE 3/17MM (K090988) LOT 114227: 30 ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2012. EXPIRATION DATE: 31-DEC-2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 4 YEARS AND 5 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP ON THE PATIENT'S LEFT AND RIGHT KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188375 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 140222 07630030817267

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention