GMK Revision Total Knee System 02.07.0410SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030817656), received between Dec 1, 2017 and May 27, 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.

• InjuryMay 27, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY LEFT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE PATIENT WAS REVISED TO MEDACTA SPACERS FOR INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2026, THE PATIENT HAD PERMANENT MEDACTA GMK-REVISION HARDWARE IMPLANTED (FEMORAL COMPONENT, INSERT, TIBIAL TRAY). 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 SEMICONSTRAINED 10MM S4 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25297686 ↗
• InjuryFeb 18, 2026Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 9 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT TO A SAME SIZE INSERT.

  Patient problems: Medical device site infection

  MAUDE report 24376304 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 DAYS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22096079 ↗
• InjuryFeb 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS AFTER 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 21320667 ↗
• InjuryApr 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19086068 ↗
• InjurySep 15, 2021Unstable

  THE PATIENT CAME IN REPORTING KNEE PAIN AND INSTABILITY AND THE CAUSE OF THE PAIN AND INSTABILITY IS UNKNOWN. 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, 02.07.0410SCF INSERT SEMICONSTRAINED 10MM S4 154250 WAS EXPLANTED AND A 02.07.0414SCF INSERT SEMICONSTRAINED 14MM S4 1908935 WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12473080 ↗
• InjuryMay 7, 2020Material Rupture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO RUPTURING THE PATELLA TENDON DURING PHYSICAL THERAPY. THE SURGEON REVISED THE POLY 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10031880 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ABOUT 2 MONTHS AFTER PRIMARY SURGERY, FOR KNEE INFECTION. I&D AND LINER SWAP PERFORMED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9785455 ↗
• InjuryDec 4, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, 1 YEAR AN 1 MONTH AFTER PRIMARY, 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 9410171 ↗
• InjuryOct 25, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING CLICKING NOISE INTO THE LEFT JOINT, 3 MONTHS AND 20 DAYS AFTER THE PRIMARY SURGERY. THE X-RAYS ANALYSIS REVEALED AN INTRA-PROSTHETIC DISLOCATION OF THE INLAY FROM THE TIBIAL BASEPLATE AND THE INLAY LOCKING SCREW LOOSENED. THE INLAY AND THE LOCKING SCREW HAVE BEEN REVISED SUCCESSFULLY. 3 DAYS AFTER THE REVISION SURGERY ((B)(6) 2019) THE PATIENT'S KNEE GOT INFECTED (STAPHYLOCOCCUS CAPITIS). THE SURGEON DID AN I&D AND NO IMPLANT HAS BEEN REVISED AT THAT TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9237713 ↗
• InjuryOct 19, 2018Microbial Contamination of Device

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7984650 ↗
• InjurySep 20, 2018Microbial Contamination of Device

  ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR INFECTION. LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7893362 ↗
• InjurySep 14, 2018Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON WAS REVISING THE PATIENT ON (B)(6) 2108 DUE TO SUSPECTED TIBIAL LOOSENING ABOUT 3 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE PATIENT ON THE PLANNED DATE BUT THE LOOSENING WAS NOT CONFIRMED, SO THE REASON FOR REVISION WAS GENERIC PAIN AND THE SURGEON REVISED THE JOINT IMPLANTING A NEW INSERT SEMICONSTRAINED 12MM S4.

  Patient problems: Joint Disorder

  MAUDE report 7876587 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information

  FOLLOWING THE VISUAL PRESENCE OF AN INFECTION THE KNEE WAS WASHED OUT SEVERAL TIME AS A PRECAUTION. AFTER THE FINAL WASHOUT THE POLY LINER WAS SWAPPED OUT FOR A NEW ONE.

  Patient problems: Unspecified Infection

  MAUDE report 7074504 ↗