GMK Total Knee SystemRecalls & reported problems across all models

We found 31 models of GMK Total Knee System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2021 and Jul 16, 2026 — classified as 50 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GMK Total Knee System problems

GMK Total Knee System models

31 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GMK Total Knee System 02.12.KA13L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  6 reports
• GMK Total Knee System 02.07.2803L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  3 reports
• GMK Total Knee System 02.07.2804R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  3 reports
• GMK Total Knee System 02.12.KA13R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  3 reports
• GMK Total Knee System 02.07.2802L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.0722R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA03R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA05L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA05R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA06R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA07L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA12L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA12R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.12.KA14R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  2 reports
• GMK Total Knee System 02.07.2804L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.07.2806R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.0703R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.0705L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.0706R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.0722L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.0723L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.0724L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.0725R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.28T3I4R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.KA02L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.KA04L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.KA14L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.KA15R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.KA16L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.12.KA16R

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report
• GMK Total Knee System 02.07.12055L

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 report

Recent GMK Total Knee System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY INSERTING ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25838710 ↗
• InjuryJul 1, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND SIGNS OF METAL ALLERGY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERIKA S5+R CEMENTED FEMORAL COMPONENT TO A GMK-HINGE FEMORAL COMPONENT SIZE5 R - TINBN COATED, REVISED THE FLEX 5R - 10MM INSERT TO A SIZE5 - 14 MM GMK-HINGE INSERT, AND REVISED THE CEMENTED RIGHT S5 TIBIAL TRAY TO A GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 5R. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain; Metal Related Pathology

  MAUDE report 25677108 ↗
• InjuryJun 24, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AT ABOUT 6 MONTHS FROM PRIMARY. PATHOGEN UNKNOWN, ALL DEVICES REVISED SUCCESSFULLY AND ANTIBIOTIC SPACER IMPLANTED. IT HAS REPORTED NO CEMENT FOUND ON THE EXPLANTS; THIS IS COMMENTED IN THE COMPLAINT INVESTIGATION.

  Patient problems: Medical device site infection

  MAUDE report 25607351 ↗
• InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING TIBIAL PAIN DUE TO A LOOSE FEMUR AND TIBIA AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA AND TESTING FOR INFECTION CAME BACK NEGATIVE. THE SURGEON REVISED THE GMK-SPHERIKA COMPONENTS (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) TO GMK-REVISION COMPONENTS (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) AND ALSO THE PATIENT`S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25297688 ↗
• InjuryMay 22, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO FEMORAL LOOSENING AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE CEMENTED FEMORAL COMPONANT AND THE INSERT (FROM 11 MM TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 25253483 ↗
• InjuryMay 21, 2026Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AT ABOUT 7 MONTHS FROM THE PRIMARY. FEMUR, TIBIA, LINER REVISED SUCCESSFULLY AND SPACER IMPLANTED. THE PATELLA IMPLANT WAS NOT REVISED. THE PATIENT HAD PAIN, AND THERE WAS A SUSPECTED LOOSENING, SO THE REVISION WAS PERFORMED FOR THIS REASON, BUT WHEN THE KNEE WAS OPENED, AN INFECTION WAS RECOGNIZED, AND NO DEVICES LOOSEING WAS DETECTED.

  Patient problems: Medical device site infection

  MAUDE report 25242305 ↗
• InjuryMay 20, 2026Malposition of Device

  REVISION SURGERY DUE TO PERSISTENT PAIN ON MEDIAL COMPARTMENT CAUSED BY SIGNIFICANT INTERNAL ROTATION OF TIBIAL TRAY FIXED CEMENTED AT 1 YEAR 3 MONTHS FROM THE PRIMARY. GMK HINGE SYSTEM SUCCESSFULLY IMPLANTED.

  Patient problems: Implant Pain

  MAUDE report 25230408 ↗
• InjuryMay 12, 2026Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERIKA FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY TO A GMK-HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148962 ↗
• InjuryMay 8, 2026Fracture

  ADDITIONAL SURGERY TO FIX FEMORAL FRACTURE AFTER 2 DAYS FROM THE PRIMARY. INLAY REVISED AS PER STANDARD PROCEDURE, NO OTHER IMPLANTS REVISED. THE SURGEON PERFORMED A WASHOUT AND PLATED THE FRACTURE. A PIN AND ROD WERE PLACED TO FIX FRACTURE CAUSING LAXITY IN THE LIGAMENTS, SO THE SURGEON REVISED THE INSERT FROM A 2R-11MM TO A 2R-13MM AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25123175 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE FEMUR. THE SURGEON OBSERVED THAT SOME OF THE CEMENT USED TO ATTACH THE FEMUR IN THE PRIMARY SURGERY DID NOT ADHERE COMPLETELY. THE SURGEON REVISED THE GMK-SPHERIKA S7 FEMORAL COMPONENT TO A GMK-REVISION S4 FEMORAL COMPONENT WITH AUGMENTS AND REVISED THE GMK-SPHERIKA 10MM INSERT TO A SEMICONSTRAINED 12MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Joint Laxity

  MAUDE report 25039774 ↗
• InjuryApr 14, 2026Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS FROM THE PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY TO ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24871652 ↗
• InjuryMar 31, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO LOOSENING OF THE FEMORAL COMPONENT ABOUT 1 YEAR AND 3 MONTHS AFTER PRIMARY SURGERY. FIRST REVISION SURGERY 8 MONTHS BEFORE DUE TO PAIN (PATELLA REVISION) MDR 2025-00725. THE CAUSE OF THE LOOSENING IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON REVISED THE FEMORAL COMPONENT, AND UPSIZED THE INSERT FROM 10MM TO 11MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24738818 ↗
• InjuryMar 31, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERIKA FEMORAL COMPONENT, 10 MM INSERT, AND S5 TIBIAL TRAY TO A GMK-REVISION FEMUR, TIBIAL TRAY AND 10 MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24738808 ↗
• InjuryMar 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO A LOOSE FEMORAL IMPLANT AND THE CAUSE IS UNKNOWN. THE SURGEON NOTED THAT THE BONE QUALITY WAS GOOD AND THERE WERE NO SIGNS OF INFECTION. ADDITIONALLY, THERE WAS NO REPORTED TRAUMA. THE SURGEON REVISED THE MEDACTA TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT TO A COMPETITOR TRAY, INSERT, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24494900 ↗
• InjuryJan 15, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY, THE PATIENT CAME REPORTING PAIN CAUSED BY ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON OBSERVED FEMORAL NOTCHING WITHOUT FRACTURE. GMK-SPHERIKA COMPONENTS WERE REVISED TO GMK-HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 24078374 ↗

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