BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1 R

    MDR report key: 18274791 · Received December 6, 2023

    Report

    Report Number
    3005180920-2023-00973
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRD DEPARTMENT. ONE YEAR AFTER PRIMARY CEMENTED TKA ON A RATHER YOUNG PATIENT, REVISION IS REQUIRED TO OVERCOME MAINLY A LAXITY PROBLEM. THIS IS FREQUENTLY GENERATED BY DISEASE PROGRESSION. IN THIS PARTICULAR CASE, AS THE REPORT SAYS THAT THE PATIENT WAS COMPLAINING FROM LAXITY SINCE THE VERY BEGINNING, IT'S ALSO POSSIBLE THAT GOOD LIGAMENT BALANCING COULD NOT BE ACHIEVED AT INDEX SURGERY. THE RADIOGRAPHS SUPPLIED DO NOT REVEAL ANYTHING PARTICULARLY TELLING; PERHAPS BOTH COMPONENTS ARE A LITTLE UNDERSIZED, BUT WE CANNOT TELL IF THIS CAN BE INFLUENTIAL FOR THE REASONS OF THE COMPLAINT. WE SEE NO REASON TO SUSPECT A DEFECTIVE IMPLANT. BATCH REVIEW PERFORMED ON 01 DECEMBER 2023 LOT 2006185: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 20-JULY-2020. EXPIRATION DATE: 2025-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 01 DECEMBER 2023 GMK-SPHERE 02.12.0110FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/10 MM R (K121416) LOT. 2012691: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-02-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 01 DECEMBER 2023 GMK-SPHERE 02.07.1201R TIBIAL TRAY FIXED CEMENTED SIZE 1 R (K090988) LOT. 2009460: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2021. EXPIRATION DATE: 2026-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY ON THE RIGHT SIDE AT ABOUT 1 YEAR 7 MONTHS AFTER THE PRIMARY DUE TO PAIN AND LAXITY. NO LOOSENING OF THE IMPLANTS. NO INFECTION. EXPLANTATION OF GMK-SPHERE IMPLANTS. IMPLANTATION OF GMK-REVISION IMPLANTS, FEMORAL DISTAL WEDGES, EXTENSION STEM AND OFFSET, WITH RESURFACING OF THE NATURAL PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771569 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2006185

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention