GMK Revision Total Knee System 02.07.0217SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030816833), received between Sep 13, 2017 and Feb 18, 2026 — classified as 11 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY SURGERY UTILIZING COMPETITOR IMPLANTS. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT, FEMUR, POST, STEMS, AND AUGMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN REPORTING A STIFF KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE INSERT AND TINBN PEG FROM 17MM TO 12MM TO IMPROVE MOVEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 24376292 ↗
• InjuryFeb 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT WITH A LOOSE KNEE FEMUR AND OVERSTRETCHED MCL AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND ADDED SOME VARUS ALIGNMENT AND USED SEMI-CONSTRAINED FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT, REVISED THE TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18648849 ↗
• InjuryJul 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, 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 17404476 ↗
• InjuryNov 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 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 15750885 ↗
• InjuryJun 13, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS DUE TO BUILT-UP SCAR TISSUE AND THE CAUSE OF THE BUILT UP SCAR TISSUE IS UNKNOWN. ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (FROM 17MM TO 14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 14673492 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 21 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION: THE PATIENT HAD A PRIMARY AND WAS IMPLANTED WITH COMPETITOR COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12505718 ↗
• InjuryApr 14, 2021Unstable

  THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2016, THE PATENT HAD THE COMPETITOR IMPLANTS REVISED TO MEDACTA IMPLANTS AND THE CAUSE OF THE REVISION IS UNKNOWN. 4 YEARS AND 9 MONTHS AFTER MEDACTA PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT SEMICONSTRAINED 17MM S2 WITH AN INSERT SEMICONSTRAINED 20MM S2 TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11663193 ↗
• InjuryMar 17, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY SURGERY AND WAS IMPLANTED WITH COMPETITOR COMPONENTS. ON (B)(6) 2021, THE PATIENT CAME IN FOR REASONS UNKNOWN AND HAD THE COMPETITOR IMPLANTS REVISED TO MEDACTA IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, 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 INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11505651 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem

  6 MONTHS AFTER REVISION SURGERY (COMPETITOR PRODUCTS WERE REVISED AND MEDACTA GMK REVISION IMPLANTED) THE PATIENT RETURNED DUE TO ANTERIOR KNEE PAIN AND PATELLAR MAL TRACKING. REVISION SURGERY WAS PERFORMED WITH LINER EXCHANGE AND PATELLAR COMPONENT EXCHANGE AND LATERAL RELEASE OF THE PATELLAR LIGAMENT (PREVIOUSLY TO THIS SURGERY THE PATELLA INSIDE WAS FROM ANOTHER MANUFACTURER).

  Patient problems: Pain

  MAUDE report 10959279 ↗
• InjuryFeb 4, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING THAT SHE WAS NOT ABLE TO GET A FULL EXTENSION 1 YEAR AND 9 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE MEDACTA INSERT SEMICONSTRAINED 17MM S2 WITH A MEDACTA INSERT SEMICONSTRAINED 14MM S2 AND COMPETITOR PATELLA WITH A MEDACTA PATELLA RESURFACING S2. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 9664319 ↗
• InjuryJul 31, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD TIBIAL LOOSENING THAT WAS CAUSED BY AN INFECTION. THE SURGEON PERFORMED A REVISION OF THE IMPLANT 1 YEAR AND 10 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8844856 ↗
• MalfunctionSep 13, 2017Misconnection; Misconnection

  WHEN IMPLANTING THE INSERT, THE INSERT WOULD NOT SEAT PROPERLY. THE SURGEON REQUESTED A SECONDARY INSERT TO COMPLETE THE SURGERY. THERE WAS APPROXIMATELY A 5 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANT IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6860922 ↗