BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 8439903 · Received March 21, 2019

    Report

    Report Number
    3005180920-2019-00179
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    February 21, 2019
    Report Date
    March 21, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 MARCH 2019: LOT 161489: 89 ITEMS MANUFACTURED AND RELEASED ON 21-APR-2016. EXPIRATION DATE: 2021-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT ADDITIONAL IMPLANTS INVOLVED: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988)LOT 162481: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2016. EXPIRATION DATE: 2021-06-09.NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT GMK-SPHERE 02.12.0004R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R (K121416), LOT 160988: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2016. EXPIRATION DATE: 2021-03-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT GMK-SPHERE 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT 155776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2015. EXPIRATION DATE: 2021-11-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS 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 157604: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2016. EXPIRATION DATE: 2021-03-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: LATE INFECTION IN CEMENTED TKA, 2.4 YEARS 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

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WITH A 6 WEEKS HISTORY OF INFLAMED KNEE AND SOME ANTIBIOTIC THERAPY: THE WOUND HAD BEEN DEBRIDED AND ANTIBIOTIC PELLETS HAD BEEN INSERTED IN SOFT TISSUE. THE PATIENT PRESENTED TO THE SURGEON WITH A SINUS OVER LATERAL TIBIA AND ASPIRATE OF KNEE JOINT HAS GROWN STAPH EPIDERMIS. ON THE NEXT DAY, 2 YEARS AND 4 MONTHS AFTER PRIMARY, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233295 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 161489 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention