GMK Revision Total Knee System 02.07.0512SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030818332), received between Jul 23, 2021 and May 15, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  AT 10 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN PRESENTING PAIN AND SEVERE FLEXION CONTRACTURE AND THE CAUSE IS UNKNOWN. THERE WERE NO REPORTS OF TRAUMA. THE SURGEON REVISED THE SEMICONSTRAINED 12MM S5 INSERT TO A SEMICONSTRAINED 10MM S5 INSERT, PERFORMEDADDITIONAL DISTAL RESECTION TO GAIN FULL EXTENSIONAND REVISED THE PS SIZE 5 R FEMUR WITH THE SAME SIZE FEMUR ALONG WITH AUGMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 25185346 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22147832 ↗
• InjuryFeb 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING. THE SURGEON REVISED ALL COMPONENTS. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21446252 ↗
• InjuryJun 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRIMARY SURGERY WAS A COMPETITOR REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 17208049 ↗
• InjuryFeb 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM FIRST MEDACTA DEVICES IMPLANTATION, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16417234 ↗
• InjuryDec 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME TO SEE THE SURGEON AFTER TAKING A BLOOD THINNER. IT WAS OBSERVED THAT THE PATIENT NEEDED A SYNOVECTOMY AS A RESULT. AT ABOUT 5 YEARS AND 3 MONTHS FROM PRIMARY THE SURGEON PERFORMED A SYNOVECTOMY AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16015098 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem

  3 WEEKS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12216924 ↗