BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 14875363 · Received June 30, 2022

    Report

    Report Number
    3005180920-2022-00510
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    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 20 JUNE 2022: LOT 2001661: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JULY-2020. EXPIRATION DATE: 2025-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 20 JUNE 2022: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 2002944 LOT 2002944: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2020. EXPIRATION DATE: 2025-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0312FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R (K121416) LOT. 2000436 LOT 2000436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2020. EXPIRATION DATE: 2025-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2003008 LOT 2003008: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2020. EXPIRATION DATE: 2025-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 7 MONTHS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914633 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0023R 2001661 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention