BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM RIGHT

    MDR report key: 6716839 · Received July 17, 2017

    Report

    Report Number
    3005180920-2017-00383
    Event Type
    Injury
    Date Received
    July 17, 2017
    Report Date
    July 14, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826788
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 JULY 2017. LOT 147289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 APRIL 2015. EXPIRATION DATE: 2020-02-29. 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. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING # 4 LOT. 141655. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JULY 2014. EXPIRATION DATE: 2019-05-31. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS SEPTIC. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY AND REVISED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497022 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 147289 07630030826788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention