GMK Total Knee System 02.12.KA13LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630345716217), received between Feb 22, 2023 and May 12, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJan 13, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD KNEE INSTABILITY DUE TO LOOSE IMPLANTS AND THE CAUSE IS UNKNOWN. THE SURGEON SUSPECTED A NICKEL ALLERGY AND AT ABOUT 1 YEAR AND 10 MONTHS POST PRIMARY REVISED THE TIBIAL TRAY AND FEMORAL COMPONENT TO SENSITIN REVISION COMPONENTS. THE SURGEON ALSO REVISED THE INSERT FROM A 10MM TO A 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24051152 ↗
• InjurySep 9, 2024Malposition of Device; Malposition of Device

  PRIMARY KNEE SURGERY PERFORMED ON (B)(6) 2024. X-RAYS TAKEN IMMEDIATELY POST-OP SHOWED THAT THE NEUTRAL ALIGNMENT WAS 187° WITH 13° OF VALGUS ON A FULL LEG. NO ISSUE HAS BEEN FOUND DURING SURGERY WITH NEXTAR. FOR THE MOMENT (B)(6) 2024) THE PATIENT IS DOING WELL AND NO REVISION IS PLANNED.

  Patient problems: Implant Pain

  MAUDE report 20167519 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO GMK-HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20046119 ↗
• InjuryJan 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A DAY AFTER THE PRIMARY KNEE SURGERY, THE PATIENT REPORTED INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON DECIDED TO REVISE THE PATIENT TO GMK-HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18524338 ↗
• InjuryFeb 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16417238 ↗