BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    MDR report key: 8964872 · Received September 5, 2019

    Report

    Report Number
    3005180920-2019-00736
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825866
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 8 AUGUST 2019: LOT 1811359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 2024-02-20. 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. ADDITIONAL IMPLANTS INVOLVED BATCH REVIEWS PERFORMED ON 8 AUGUST 2019: GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988), LOT 1810474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2019. EXPIRATION DATE: 2024-02-25. 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. GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT 187985: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2019. EXPIRATION DATE: 2024-01-09. 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. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 1810562: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2019. EXPIRATION DATE: 2024-02-26. 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

    THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED THE SPHERE FEMUR CEMENTED RIGHT S5, GMK TIBIAL TRAY CEMENTED RIGHT S4, GMK SPHERE INSERT FLEX RIGHT 10MM S4, AND PATELLA RESURFACING S2. THE SURGEON IMPLANTED MEDACTA FULL-PE COMPONENTS WITH ANTIBIOTIC CEMENT TO ACT AS A TEMPORARY SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758429 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 1811359 07630030825866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention