BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L

    MDR report key: 7344703 · Received March 16, 2018

    Report

    Report Number
    3005180920-2018-00154
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862656
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 MARCH 2018. LOT 141423: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2014 . EXPIRATION DATE: 2019-03-31. 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 COMPLAINING OF ANTERIOR KNEE PAIN. THE SURGEON BELIEVES THAT RESURFACING THE PATELLA WOULD ALLEVIATE THE PAIN. THE SURGEON RESURFACED THE PATELLA AND UPSIZED THE POLY FROM A 13MM TO A 17MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF PAIN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188801 TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 141423 07630030862656

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention