BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    MDR report key: 10458489 · Received August 27, 2020

    Report

    Report Number
    3005180920-2020-00558
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 07.08.2020: LOT 171809: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUN-2017. EXPIRATION DATE: 2022-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 07.08.2020: GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 170430. LOT 170430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2017. EXPIRATION DATE: 2022-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT. 162488. LOT 162488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2016. EXPIRATION DATE: 2021-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT. 175532. LOT 175532: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2017. EXPIRATION DATE: 2022-10-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX #5/12 MM L (K121416) LOT. 1811464. LOT 1811464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 5 MONTHS FROM THE LAST REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL COMPONENTS AND IMPLANTED NEW COMPONENTS THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS PATIENT HAD 2 REVISION SURGERY PREVIOUSLY DUE TO AN INFECTION WHERE ONLY THE INSERT WAS SWAPPED (FOR BOTH CASES). THIS REVISION SURGERY HAPPENED 2 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923518 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0025L 171809 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention