GMK 02.12.E003RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630971260993), received between Jul 16, 2024 and Apr 30, 2026 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATELLA AND FEMORAL COMPONENT TO A SAME SIZE PATELLA AND FEMORAL COMPONENT. THE SURGEON REVISED THE 10MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25039770 ↗
• InjuryFeb 20, 2026Device Dislodged or Dislocated

  AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE PAIN AS A RESULT OF CHRONIC DISLOCATION OF THE PATELLA AND THE CAUSE IS UNKNOWN. PREVIOUS DISLOCATIONS CORRECTED WITH REDUCTION. THE SURGEON REVISED THE FEMUR, TIBIAL COMPONENT, AND INSERT FROM GMK-SPHERIKA TO GMK-REVISION TO ADDRESS THE DISLOCATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24399531 ↗
• InjuryJul 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS 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 PATIENT UNDERWENT REMOVAL OF THE ANTIBIOTIC SPACERS ON (B)(6) 2025, FOLLOWED BY IMPLANTATION OF THE PERMANENT HARDWARE THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22664405 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED PATELLA TENDON AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED PATELLA TENDON REPAIR AND REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19749118 ↗