GMK Revision Total Knee System 02.07.0417SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030817991), received between Jan 25, 2019 and Aug 3, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Device Appears to Trigger Rejection

  The patient had primary surgery using competitor products. On (b)(6) 2025, the patient was revised to Medacta GMK-Revision implants. On (b)(6) 2025, the patient came in with inflammation/infection over incision site with unknown cause. The surgeon performed washout and revised the knee implant. The surgery was completed successfully "[MDR 2025-00787]". Presently, on (b)(6)2026, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the 17mm S4 semiconstrained insert to a same size insert. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50114128 ↗
• InjuryMay 8, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR IMPLANTS AND ON (B)(6) 2024, WAS REVISED TO MEDACTA GMK-REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS DIAGNOSED WITH A PERFORATED DIVERTICULITIS WHICH THEN LED TO EFFUSION AND REDNESS IN THEIR RIGHT KNEE. THE SURGEON PERFORMED A WASHOUT, SOFT TISSUE RELEASE AND REVISED THE SEMICONSTRAINED 17MM S4 INSERT TO A SEMICONSTRAINED 20MM S4 INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25123200 ↗
• InjuryApr 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION 5 YEARS AND 2 MONTHS AFTER FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. THE SURGEON PERFORMED A WASHOUT AND UPSIZED THE SEMICONSTRAINED 17MM S4 LINER TO A SEMICONSTRANED 23MM S4 LINER AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24826100 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER THE 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19039584 ↗
• InjurySep 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 4 MONTHS FROM THE 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17743955 ↗
• InjuryMar 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS 8 MONTHS AFTER THE MEDACTA 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 16512020 ↗
• InjuryDec 13, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR HARDWARE. ON (B)(6) 2021, THE PATIENT CAME IN AND HAD THE COMPETITOR HARDWARE REVISED TO MEDACTA HARDWARE FOR REASONS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 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. ON (B)(6), THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12983265 ↗
• InjuryNov 30, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR HARDWARE. ON (B)(6) 2021, THE PATIENT CAME IN AND HAD THE COMPETITOR HARDWARE REVISED TO MEDACTA HARDWARE FOR REASONS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 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. ON (B)(6) 2021, 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 12891163 ↗
• InjuryJun 7, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT SEMICONSTRAINED 17MM WITH A 23MM ONE 3 YEARS AND 5 MONTHS AFTER PRIMARY TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11946023 ↗
• InjuryApr 13, 2021Appropriate Device Problem Term/Code Not Available

  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. THE LINER WAS IMPLANTED IN THE PATIENT 1 MONTH BEFORE THIS REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 11654719 ↗
• InjurySep 2, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO THE POLY BEING LAX IN FLEXION. THE CAUSE OF THE LAX POLY IS UNKNOWN. THE SURGEON REVISED THE LINER WITH A HIGHER ONE (26MM) 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10481248 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON SUBSEQUENTLY PERFORMED AN I&D AND POLY SWAP ON (B)(6) 2019 AND COMPLAINT (B)(4) WAS FILED. PRESENTLY 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9086485 ↗
• InjuryFeb 8, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 1 MONTH AND A HALF THE SURGEON REVISED THE PATIENT FOR AN INFECTION. I&D AND LINER SWAP PERFORMED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8319906 ↗
• InjuryJan 25, 2019Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SUBLUXED TIBIA 10 DAYS AFTER PRIMARY. THE SURGEON DETERMINED THAT A POLY SWAP WAS NEEDED DUE TO THE SUBLUXED TIBIA. IT IS UNCLEAR AT THIS TIME WHAT CAUSED THE SUBLUXED TIBIA. THE 17 SC POLY WAS REMOVED AND REPLACED WITH A 26 SC POLY.

  Patient problems: Pain

  MAUDE report 8277364 ↗