GMK Revision Total Knee System 02.07.0326SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030817564), received between Oct 25, 2021 and Sep 27, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2021 THE PATIENT HAD PRIMARY SURGERY WITH COMPETITOR IMPLANTS. ON (B)(6) 2021, COMPETITOR IMPLANTS WERE REVISED WITH MEDACTA IMPLANTS. ABOUT TWO YEARS AND 1 MONTH LATER, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17825074 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 3 MONTHS AFTER THE PREVIOUS REVISION SURGERY DUE TO INSTABILITY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO GMK HINGE. THE PATIENT HAD ALREADY UNDERWENT TO DIFFERENT SURGERIES DUE TO MULTIPLE INFECTIONS.

  Patient problems: Joint Laxity

  MAUDE report 17325436 ↗
• InjuryMar 19, 2022Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO FALLING AND FRACTURING THE PATELLA. THE SURGEON PERFORMED A PATELLECTOMY AND RETINACULUM REPAIR AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A QUAD TENDON RUPTURE AND THE CAUSE OF THE QUAD TENDON RUPTURE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, 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 13820165 ↗
• InjuryNov 23, 2021Material Rupture

  AT 1 MONTH AFTER THE LAST SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A QUAD TENDON RUPTURE AND THE CAUSE OF THE QUAD TENDON RUPTURE IS UNKNOWN. THE SURGEON PERFORMED A QUAD TENDON REPAIR AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PREVIOUS REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO A FALL AND PATELLA BONE RUPTURE. THE SURGEON PERFORMED A PATELLECTOMY AND RETINACULUM REPAIR AND REVISED THE LINER.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 12859348 ↗
• InjuryOct 25, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY ON (B)(6) 2015. ON (B)(6) 2017, THE PATIENT CAME IN REPORTING INSTABILITY AND NO TRAUMA CAUSED THE INSTABILITY. THE SURGEON REVISED THE INSERT AND SURGERY WAS COMPLETED SUCCESSFULLY. AT 4 YEARS AND 7 MONTHS AFTER, 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 12687962 ↗