BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM R

    MDR report key: 11907495 · Received May 31, 2021

    Report

    Report Number
    3005180920-2021-00453
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 3, 2021
    Report Date
    September 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862588
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION WAS CORRECTED BASED ON THE NEW INFORMATION RECEIVED ON AUGUST 09, 2021: THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND REVISED THE SPHERE INSERT FLEX RIGHT 11MM S3 WITH A SPHERE INSERT FLEX RIGHT 11MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND PUT A TEMPORARY SPACER (REVISED ALL THE COMPONENTS). THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE SURGEON REMOVED THE SPACER AND PUT IN PERMANENT HARDWARE IN ADDITION, HERE BELOW THERE ARE THE OTHER ITEMS INVOLVED IN THE EVENT WITH K-NUMBERS, REFERENCES AND DESCRIPTION. THE BATCH REVIEW WAS ALREADY REPORTED IN THE INITIAL. GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT. 1901837. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 1905247.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND REVISED THE SPHERE INSERT FLEX RIGHT 11MM S3 WITH A SPHERE INSERT FLEX RIGHT 11MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND PUT A TEMPORARY SPACER (REVISED ALL THE COMPONENTS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MAY 2021: LOT 1906890: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2019. EXPIRATION DATE: 2024-09-01. 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. LOT 1901837: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-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 SIMILAR REPORTED EVENT. LOT 1905247: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-DEC-2019. EXPIRATION DATE: 2024-11-23. 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 HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND REVISED THE SPHERE INSERT FLEX RIGHT 11MM S3 WITH A SPHERE INSERT FLEX RIGHT 11MM S3. THE SURGERY WAS COMPLETED SUCCESSFULLY. CURRENTLY ON (B)(6) 2021, 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803175 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0311FR 1906890 07630030862588

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention