BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    MDR report key: 15409150 · Received September 13, 2022

    Report

    Report Number
    3005180920-2022-00697
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 13, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825828
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 AUGUST 2022. LOT 2101894: 54 ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2021. EXPIRATION DATE: 2026-MAR-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 51 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANTS BATCH REVIEW PERFORMED ON 24 AUGUST 2022 ON GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT. 2011075. LOT 2011075: 134 ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-FEB-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 127 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 24 AUGUST 2022 ON GMK-SPHERE 02.12.0212FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R (K121416) LOT. 2100080. LOT 2100080: 30 ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-MAR-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 24 AUGUST 2022 ON GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2101550. LOT 2101550: 240 ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-MAR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 227 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756143 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0003R 2101894 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention