BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7150721 · Received December 28, 2017

    Report

    Report Number
    3005180920-2017-00790
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 28, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 DECEMBER 2017 LOT 172817: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JULY 2017. EXPIRATION DATE: 2022-06-26 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

    REVISION SURGERY 23 DAYS AFTER PRIMARY DUE TO INFECTION. THREE CULTURES RETURNED POSITIVE FOR PASTEURELLA PENICILLIN RESISTENT. ANAMNESIS REVIALED THAT THE PATIENT IS USE TO SLEEP WITH HER DOG IN HER BED. AFTER BEING DIAGNOSED WITH ACUTE POSTOPERATIVE INFECTION, SHE WAS OPERATED ON (B)(6) 2017 FOR IRRIGATION AND DÉBRIDEMENT AND LINER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931008 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 172817 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention