BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R

    MDR report key: 9284062 · Received November 6, 2019

    Report

    Report Number
    3005180920-2019-00933
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 8, 2019
    Report Date
    November 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825804
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2019: LOT 180957: 68 ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2018. EXPIRATION DATE: 2023-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 54 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 1 YEAR AFTER PRIMARY CEMENTED TKA THE FEMUR IS EXCHANGED TO A REVISION COMPONENT OF SMALLER SIZE AND THE PATELLA IS RESURFACED. THE ANTERIOR PAIN REPORTED BY THE PATIENT MAY BE DUE TO THE EXCESSIVE SIZE OF THE PRIMARY FEMORAL COMPONENT AND THE EMPTY VOLUME BETWEEN ANTERIOR SHIELD AND BONE. NO REASON TO SUSPECT A FAULTY DEVICE IN THIS CASE.

    Description of Event or Problem · 1

    THE X-RAYS SHOWED THAT THE FEMORAL IMPLANT IN PLACE WAS TOO BIG FOR THE PATIENT BONE. THE PATIENT WAS REVISED 1 YEAR AFTER PRIMARY BECAUSE HAD ANTERIOR KNEE PAIN. FEMORAL COMPONENTS SWAP AND PATELLA RESURFACING PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080265 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 180957 07630030825804

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention