BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    MDR report key: 13468874 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00081
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 13, 2022
    Report Date
    February 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 JANUARY 2022. LOT 2003252: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2020. EXPIRATION DATE: 2025-JUL-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT. 2001625. BATCH REVIEW PERFORMED ON 20 JANUARY 2022. LOT 2001625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2020. EXPIRATION DATE: 2025-JUN-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0413CRR TIBIAL INSERT FIXED SPHERE CR SIZE 4/13 MM R (K181635) LOT. 1901355. BATCH REVIEW PERFORMED ON 20 JANUARY 2022. LOT 1901355: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. EXPIRATION DATE: 2024-JUN-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT. 2006038. BATCH REVIEW PERFORMED ON 20 JANUARY 2022. LOT 2006038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2020. EXPIRATION DATE: 2025-JUL-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447842 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0024R 2003252 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention