GMK Total Knee System 02.12.KA06RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716149), received between Oct 17, 2025 and Mar 31, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT TKA ON (B)(6) 2024. ON (B)(6) 2024 AT FOLLOWUP THE PATIENT REPORTED ANTERIOR KNEE PAIN. TEST FOR INFECTION WERE NEGATIVE. SURGEON CONCLUSION WAS THAT THE PAIN WAS DUE TO PATELLA REMODELING AND THAT IT WOULD NATURALLY IMPROVED OVER TIME. ON (B)(6) 2024 PATIENT STILL REPORTED PAIN. SURGEON SCHEDULED PATELLA RESURFACING FOR (B)(6) 2025 BUT PATIENT CANCELLED THE PROCEDURE ON (B)(6) AND COULD NOT BE CONTACTED ANYMORE. IT IS UNKNOWN IF THE PATIENT UNDERWENT ADDITIONAL OR REVISION SURGERY OR ANY OTHER TREATMENT.

  Patient problems: Implant Pain

  MAUDE report 23321317 ↗