BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 15240041 · Received August 17, 2022

    Report

    Report Number
    3005180920-2022-00610
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 18, 2022
    Report Date
    August 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JULY 2022 ON LOT 2002933: LOT 2002933: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 2025-MAY-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED ON 17 AUGUST 2022: FEW WEEKS AFTER PRIMARY TKA AN INFECTION DEVELOPS AND REQUIRES REMOVAL OF THE IMPLANTS. EARLY PERI-PROSTHETIC INFECTIONS ARE A KNOWN, POSSIBLE ADVERSE EVENT RELATED TO THE ARTHROPLASTY PROCEDURE, BROADLY DESCRIBED IN LITERATURE. NO REASON TO SUSPECT A DEFECTIVE IMPLANT AT THE ORIGIN OF THIS EVENT. ADDITIONAL IMPLANTED COMPONENTS. BATCH REVIEW PERFORMED ON 25 JULY 2022 ON GMK-SPHERE 02.12.0412CRL TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM L (K181635) LOT. 2002127. LOT 2002127: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2020. EXPIRATION DATE: 2025-MAY-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 25 JULY 2022 ON GMK-SPHERE 02.12.1004L FEMORAL COMPONENT SPHERE CEMENTLESS SIZE 4 L LOT. 2108427. LOT 2108427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 2026-OCT-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222342 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2002933 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention