BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM RIGHT

    MDR report key: 6964504 · Received October 20, 2017

    Report

    Report Number
    3005180920-2017-00606
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 17 OCTOBER 2017. LOT 162173: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 JULY 2016. EXPIRATION DATE: 2021-06-21. 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. GMK-SPHERE PATELLA RESURFACING SIZE 2, CODE 02.07.0034RP, LOT. 166887 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JANUARY 2017. EXPIRATION DATE: 2022-01-12. 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 COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE PATELLA WAS NOT TRACKING PROPERLY. THE SURGEON SWAPPED THE 10MM POLY FOR A 14MM POLY. ONLY THE LINER WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744393 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 162173 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention