GMK Revision Total Knee System 02.07.0214SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630030816710), received between Oct 31, 2017 and Jul 9, 2026 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 3 YEARS AND 7 MONTHS FROM FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE TINBN COATED SC.

  Patient problems: Medical device site infection

  MAUDE report 25763499 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH INSTABILITY OF UNKNOWN CAUSE. THE SURGEON UPSIZED BOTH THE INSERT AND THE PEG FROM 14 MM TO 17 MM TO IMPROVE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23437043 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 11 MONTHS, THE PATIENT CAME IN DUE TO INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE POLY TO PROVIDE MORE STABILITY (14 TO 20MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22949798 ↗
• InjuryNov 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT UNDERGONE A PRIMARY SURGERY WITH COMPETITOR IMPLANTS. ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED AND GMK-REVISION COMPONENTS HAVE BEEN IMPLANTED. ON THE (B)(6) 2024, 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 20621603 ↗
• InjuryOct 17, 2024Device 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 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20469414 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. AT ABOUT 3 WEEKS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16813630 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO MEDIAL AND LATERAL LIGAMENT INSTABILITY. THE SURGEON REVISED SUCCESSFULLY THE GMK REVISION SYSTEM AND IMPLANTED GMK HINGE COMPONENTS.

  Patient problems: Pain

  MAUDE report 16415687 ↗
• InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON 26 (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 ALL COMPONENTS AND 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: Medical device site infection

  MAUDE report 15868759 ↗
• InjuryJul 16, 2021Appropriate Device Problem Term/Code Not Available

  1 MONTH 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 12179427 ↗
• InjuryApr 20, 2021Appropriate Device Problem Term/Code Not Available

  1 MONTH 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 INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11692001 ↗
• InjuryMar 16, 2020Loose or Intermittent Connection

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR PRODUCTS. THE PATIENT HAD A REVISION KNEE SURGERY ON (B)(6) 2019 AND WAS IMPLANTED WITH MEDACTA HARDWARE. ON (B)(6) 2020, THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO LAXITY IN THE KNEE. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA INSERT SEMICONSTRAINED 14MM S2 TO A MEDACTA INSERT SEMICONSTRAINED 17MM S2. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9834852 ↗
• InjurySep 27, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO PAIN CAUSED BY A SUPERFICIAL WOUND AND DRAINING DISTAL TO THE WOUND. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP SUCCESSFULLY. INFECTION IS NOT CONFIRMED.

  Patient problems: Pain

  MAUDE report 9128547 ↗
• InjuryOct 31, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO INFECTION. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE POLY HAS BEEN EXCHANGED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6990447 ↗