BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R

    MDR report key: 10926402 · Received December 1, 2020

    Report

    Report Number
    3005180920-2020-00875
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862670
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 NOVEMBER 2020: LOT 164458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2016. EXPIRATION DATE: 2021-09-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 19 NOVEMBER 2020: GMK-SPHERE 02.12.0026R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R (K140826) LOT 184867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2018. EXPIRATION DATE: 2023-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 184114: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2018. EXPIRATION DATE: 2023-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 184114: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2018. EXPIRATION DATE: 2023-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT 1904316: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2019. EXPIRATION DATE: 2024-08-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 6 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391481 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0513FR 164458 07630030862670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention