BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+

    MDR report key: 12982990 · Received December 13, 2021

    Report

    Report Number
    3005180920-2021-00969
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-DEC-2021. LOT 1909485: (B)(4). EXPIRATION DATE: 2025-MAR-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL DEVICES INVOLVED: GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L (K121416) LOT. 1909425; LOT 1909425: (B)(4). EXPIRATION DATE: 2024-NOV-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT. 1909601; LOT 1909601: (B)(4). EXPIRATION DATE: 2025-MAR-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT. 2006038; LOT 2006038: (B)(4). EXPIRATION DATE: 2025-JUL-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 10 MONTHS AFTER THE PRIMARY SURGERY AND IT WAS DETERMINED THAT THE PATIENT NEEDED TO BE CONVERTED BECAUSE THE QUADRICEP WAS NOT STRONG ENOUGH AND WAS CAUSING THE KNEE TO HYPEREXTEND. ALL COMPONENTS WERE REVISED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887140 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0025L 1909485 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention