GMK 02.12.E002RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630971260986), received between Sep 29, 2022 and May 23, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22078238 ↗
• InjuryMar 25, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATED PATELLA IMPLANT AND KNEE INSTABILITY. THE SURGEON REVISED THE 17MM POLY WITH A 20MM POLY AND PERFORMED A LATERAL RELEASE AND VMO ADVANCEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21687575 ↗
• InjuryJul 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 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 THE LINER AND PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19641740 ↗
• InjuryMay 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN DUE TO ASEPTIC PATELLA IMPLANT LOOSENING. ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, CHANGED THE LINER (PER STANDARD PROCEDURE), AND REVISED THE PATELLA IMPLANT (WITH ONE OF THE SAME REF) TO CHANGE ITS POSITION AND HELP WITH PATELLA TRACKING.

  Patient problems: Implant Pain

  MAUDE report 19266605 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AND HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AFTER A PHYSICAL THERAPY SESSION. THE PATIENT HAD ALSO SOME GAIT ISSUES. THE SURGEON NOTED THAT THE CUT PERFORMED DURING THE PRIMARY WAS NOT THE BEST SO HE DECIDED TO REVISE THE PATELLA IMPLANT AND RECUT THE PATELLA TO GIVE A DIFFERENT ORIENTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15509028 ↗