GMK Primary Total Knee System 02.07.1204LRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07630030819902), received between Dec 20, 2017 and Aug 11, 2026 — classified as 58 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (19 reports).

1 other recall cover devices cleared under the same FDA submission (K090988); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Device Appears to Trigger Rejection

  At about 1 year and 9 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-Sphere cemented S4 tibial tray to a Rev. Tibial Tray Left S4 and revised the Flex 4L - 11mm insert to a Flex 4L - 13mm at his discretion. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50209598 ↗
• InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 5 DAYS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22539700 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND IMPLANTED A TIBIAL CONE AND EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22384187 ↗
• InjuryJun 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 20 DAYS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22269609 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 9 DAYS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22148004 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 4 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON DECIDED TO REVISE THE PATIENT, AND DURING THE REVISION IT WAS OBSERVED THAT THE PRIMARY IMPLANTS WERE ALL LOOSE WITH LITTLE TO NO CEMENT ADHERENCE. THE SURGEON REVISED ALL IMPLANTS TO GMK-REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21772690 ↗
• InjuryMar 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A METAL ALLERGY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 4 MONTHS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS TO SENSITIN COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21524142 ↗
• InjuryFeb 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS, 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING MID-FLEXION INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21408529 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 11 MONTHS THE PATIENT CAME IN REPORTING INSTABILITY. NO LIGAMENT DETERIORATION REPORTED. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21320173 ↗
• InjuryAug 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PAIN DUE TO A NICKEL ALLERGY. AT ABOUT 2 YEARS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS TO SENSITIN COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20062858 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OVERHANG OF THE TIBIAL PLATE ON THE INTERNAL PART AND INSTABILITY, ESPECIALLY IN THE MEDIAL REGION OF THE KNEE. MOREOVER, THE PATIENT DESCRIBED ANTERIOR KNEE PAIN. THE SURGEON REVISED ALL THE GMK SPHERE COMPONENTS AND IMPLANTATION OF GMK-REVISION COMPONENTS AND RESURFACED THE PATELLA BONE.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 20032989 ↗
• InjuryAug 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA IMPLANT, TIBIAL TRAY, POLY AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 19936763 ↗
• InjuryAug 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 10 MONTHS FROM PRIMARY THE SURGEON REVISED THE TIBIAL TRAY, POLY, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 19936762 ↗
• InjuryMay 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 1 MONTH POST-PRIMARY THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19236388 ↗
• InjuryApr 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19178382 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18703839 ↗
• InjuryJan 31, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT CAME IN REPORTING INSTABILITY AND PAIN DUE TO TIBIAL SUBSIDENCE AND THE CAUSE IS UNKNOWN. ABOUT 5 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS WITH HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 18612807 ↗
• InjuryDec 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 6 YEARS AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIAL TRAY. THE SURGEON REVISED THE MEDACTA FEMORAL COMPONENT, INSERT AND TIBIAL TRAY WITH COMPETITOR IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18334736 ↗
• InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND RE-IMPLANTED PERMANENT COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18111193 ↗
• InjurySep 22, 2023Migration; Migration

  REVISION SURGERY AT 2 YEARS AND 8 MONTHS POST PRIMARY FOR TIBIAL TRAY SUBSIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798744 ↗
• InjuryJul 7, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS 4 MONTHS AFTER THE PRIMARY, REVISION SURGERY FOR CEMENTED TIBIAL TRAY LOOSENING. THE SURGEON REVISED SUCCESSFULLY. THE SYSTEM TO REVISION.

  Patient problems: Insufficient Information

  MAUDE report 17276803 ↗
• InjuryMay 12, 2023Malposition of Device; Malposition of Device

  ABOUT 5 YEARS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO MALPOSITIONING OF THE TIBIAL TRAY (THE TIBIA HAS TILTED BACKWARD). HINGE SYSTEM IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16917740 ↗
• InjuryApr 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CEMENTED TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16783331 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INSTABILITY AT 1 YEAR AND 5 MONTHS AFTER PRIMARY DUE TO LIGAMENT ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON IS SURPRISED THAT THE CEMENT HAS NOT STUCK TO THE TIBIA. COMPETITOR HINGE SYSTEM IMPLANTED IN THE PATIENT.

  Patient problems: Damage to Ligament(s)

  MAUDE report 16160070 ↗
• InjuryAug 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15319227 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090988. One submission often covers many models, so check the product and lot details in each record.

• Z-0266-2018 · Oct 24, 2017 · Terminated
  The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0