BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L

    MDR report key: 10194903 · Received June 25, 2020

    Report

    Report Number
    3005180920-2020-00362
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10 JUNE 2020: LOT 188923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2019. EXPIRATION DATE: 2023-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 10 JUNE 2020: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 1902683: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2019. EXPIRATION DATE: 2024-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT 1903253: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2019. EXPIRATION DATE: 2024-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 1902820: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2019. EXPIRATION DATE: 2024-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW MONTHS AFTER PRIMARY CEMENTED TKA AN INFECTION DEVELOPED AND LED TO REVISION. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO AN INFECTION (PATHOGEN UNKNOWN). ALL IMPLANTS REPORTED WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659602 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0024L 188923 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention