BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 9443713 · Received December 10, 2019

    Report

    Report Number
    3005180920-2019-01055
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    October 18, 2019
    Report Date
    December 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019. LOT 1901886: 50 ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-06-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0313FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R (K140826) LOT. 175256. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019. LOT 175256: 30 ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2017. EXPIRATION DATE: 2022-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 1902703. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019. LOT 1902703: 53 ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-07-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER. EARLY INFECTION IN CEMENTED TKA, FEW WEEKS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, ONE MONTH AFTER PRIMARY SURGERY, DUE TO INFECTION. ALL COMPONENTS HAVE BEEN SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241406 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 1901886 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention