GMK Revision Total Knee System 02.07.0684RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030819391), received between Apr 12, 2019 and Jan 15, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2019, THE PATIENT WAS REVISED FROM THE COMPETITOR IMPLANTS TO MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO INSTABILITY AS A RESULT OF THE LOOSENING IMPLANTS OF THE TIBIA AND FEMUR. THE SURGEON REVISED THE FEMUR, TRAY, AND INSERT TO A GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 24078373 ↗
• InjuryDec 19, 2019Fitting Problem; Appropriate Device Problem Term/Code Not Available

  THE SURGEON ATTEMPTED TO LOCK THE SEMI-CONSTRAINED POLY INTO THE TIBIA BUT IT WAS NOT POSSIBLE. AFTER 20 MINUTES, THE AGENT OPENED UP ANOTHER SEMI-CONSTRAINED POLY FOR THE SURGEON TO USE, AND THAT DID NOT LOCK IN EITHER. THE AGENT OPENED THEN A PS POLY AND IT DIDN'T SEAT EITHER. THE SURGEON OBSERVED THAT THE TIBIA BASEPLATE LOCKING MECHANISM WASN'T MACHINED IN TO HAVE THE POLY LOCKED INTO IT. THE SURGEON DECIDED AT THIS POINT TO EXPLANT THE WHOLE TIBIAL CONSTRUCT (BASEPLATE, CONE, OFFSET, STEM, AND MEDIAL/LATERAL TIBIAL AUGMENTS) AND REPLACED THE COMPONENTS WITH A NEW BASEPLATE, CONE, OFFSET, STEM, AND MEDIAL/LATERAL TIBIAL AUGMENTS, AND UPSIZED TIBIAL BASEPLATE AND A SEMI-CONSTRAINED POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A 50-MINUTE DELAY IN THE CASE. ADDITIONAL ANAESTHESIA WAS NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9494243 ↗
• InjuryApr 12, 2019Device Slipped

  THE PATIENT CAME IN, 3 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE TIBIAL TRAY. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8508146 ↗