GMK Revision Total Knee System 02.07.0414SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030817878), received between Mar 27, 2018 and May 27, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25297698 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 1 MONTH DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SEMICONSTRAINED 14MM S4 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25230411 ↗
• InjuryOct 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. (MDR (B)(4)) ON (B)(6) 2025 ALL DEVICES HAVE BEEN REVISED FOR INFECTION AND A SPACER WAS IMPLANTED. ON (B)(6) 2025 THE SPACER WAS REMOVED AND FINAL DEVICES IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23357727 ↗
• InjuryMay 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 3 MONTHS FROM 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 22002798 ↗
• InjuryDec 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INTRA-PROSTHETIC DISLOCATION OF THE LINER FROM THE TIBIAL BASEPLATE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT IS 7 WEEKS OUT STATUS POST REVISION KNEE. HAS A SEMI CONSTRAINED KNEE WITH CONES AND STEMS DOWN TIBIA AND FEMUR. ONE DAY HE STOOD UP PIVOTED AND HEARD A POP AND BECAME UNSTABLE. THIS IS A REVISION OF MEDACTA REVISION PARTS. THE PRIMARY SURGERY WAS NOT MEDACTA PARTS.

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

  MAUDE report 18382171 ↗
• InjuryJul 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ONE MONTH 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: Medical device site infection

  MAUDE report 17378590 ↗
• InjuryMay 20, 2023Device 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 WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR COMPONENTS BEFORE MEDACTA REVISION COMPONENTS.

  Patient problems: Medical device site infection

  MAUDE report 16970518 ↗
• InjuryApr 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 14 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16673622 ↗
• InjuryMar 24, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 4 MONTHS AFTER PRIMARY FOR KNEE INFECTION. LINER REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13888076 ↗
• InjuryMay 27, 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 HAD THE COMPETITOR HARDWARE REVISED TO MEDACTA HARDWARE FOR REASONS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 1 MONTH AFTER MEDACTA DEVICES IMPLANTATION, 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 11893851 ↗
• InjuryMay 5, 2021Unstable

  1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT SEMICONSTRAINED 14MM S4 WITH AN INSERT SEMICONSTRAINED 17MM S4 TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11776425 ↗
• InjuryMar 26, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A UNICOMPARTMENTAL KNEE IMPLANTED IN 2016 THAT WAS REVISED WITH MEDACTA IMPLANTS IN 2017. NOW, THE PATIENT FELL ON HIS KNEE AND CAME IN WITH PAIN. THE METAL PEG OF THE INLAY HAS BEEN FOUND UNSCREWED (AFTER ABOUT 3 YEARS AND 5 MONTHS FROM THE PREVIOUS SURGERY). DURING THE LAST REVISION SURGERY, THE SURGEON CHANGED THE INSERT TO A HIGHER ONE (17MM) AND TIGHTENED THE SCREW.

  Patient problems: Fall; Pain

  MAUDE report 11575060 ↗
• InjuryDec 13, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 5 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10998944 ↗
• InjurySep 8, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE FULL-PE PS TIBIAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10501586 ↗
• InjurySep 17, 2019Unstable

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO INSTABILITY 3 YEARS AND 8 MONTHS AFTER PRIMARY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA INSERT SEMICONSTRAINED 14MM S4 POLY WITH A MEDACTA INSERT SEMICONSTRAINED 17MM S4 POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9075825 ↗
• InjuryMay 9, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY TKA ON (B)(6) 2017. SHE CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON SUBSEQUENTLY REVISED THE FEMORAL COMPONENT, POLY AND PERFORMED A WASHOUT ON (B)(6) 2019 AND COMPLAINT (B)(4) WAS FILED. PRESENTLY, TWO MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN AGAIN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8595277 ↗
• InjuryJun 26, 2018Contamination

  REVISION SURGERY AFTER ABOUT 1 YEAR AND 8 MONTHS DUE TO SIGN OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7637643 ↗
• InjuryMar 27, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 2 YEARS AFTER PRIMARY. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON REVISED THE PATELLA AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7372841 ↗