GMK Revision Total Knee System 02.07.0514SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630030818455), received between Nov 8, 2017 and May 22, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2025, THE SURGEON REVISED THE PATIENT TO MEDACTA GMK-REVISION IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING ANTERIOR PAIN AND INSTABILITY. THE SURGEON REVISED THE SEMICONSTRAINED 14MM S5 INSERT TO A SEMICONSTRAINED S5 17MM INSERT AND REVISED THE PATIENT`S NATURAL PATELLA USING COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25253492 ↗
• InjuryMar 16, 2026Device Appears to Trigger Rejection

  SECOND REVISION SURGERY DUE TO INFECTION 3 MONTHS AFTER FIRST REVISION SURGERY.THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR IMPLANTS. THE SURGEON PERFORMED A WASHOUT AND THEN REVISED THE 14MM SIZE 5 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24603544 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  8 MONTHS AFTER THE PREVIOUS SURGERY, THE PATIENT PRESENTED WITH PATELLAR TRACKING ISSUES OF UNKNOWN CAUSE. THE SURGEON REMOVED THE COMPETITOR PATIENT'S PATELLA AND REVISED THE MEDACTA LINER FROM 14 MM TO 17 MM, PROBABLY DUE TO KNEE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23858478 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (14 TO 17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22936827 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE DUE TO SCAR TISSUE THAT HAD DEVELOPED. THE SURGEON CLEANED OUT THE SCAR TISSUE AND DOWNSIZED THE POLY (FROM 14 TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 19749119 ↗
• InjuryNov 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR KNEE INFECTION AT 5 YEARS AND 4 MONTHS FROM PRIMARY FOR INFECTION. THE KNEE LINER HAS BEEN REVISED SUCCESSFULLY. PATIENT HAD COMPEITITOR COMPONENTS BEFORE GMK-REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 18191309 ↗
• InjuryApr 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 6 YEARS AND 5 MONTHS AFTER THE FIRST REVISION SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (14MM) WITH A THICKER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING THE FIRST REVISION SURGERY, THE PATIENT WAS REVISED FROM COMPETITOR COMPONENTS TO MEDACTA GMK REVISION SYSTEM.

  Patient problems: Joint Laxity

  MAUDE report 16759676 ↗
• InjuryMar 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ABOUT 6 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING. WHEN THE SURGEON OPENED THE PATIENT UP, THE POLY POPPED RIGHT OUT. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS PREVIOUSLY REVISED FROM COMPETITOR'S COMPONENTS TO GMK REVISION SYSTEM.

  Patient problems: Implant Pain

  MAUDE report 16644030 ↗
• InjurySep 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT WAS REVISED FROM COMPETITOR COMPONENTS TO MEDACTA ON (B)(6) 2022. 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: Unspecified Infection

  MAUDE report 15494323 ↗
• InjuryApr 25, 2022Unstable

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2012. ON (B)(6) 2020 THE SURGEON REVISED ALL IMPLANTS FOLLOWING MOBILIZATION. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON TRIALED A 17MM INSERT BUT IT WAS NOT POSSIBLE TO GET THE LEG STRAIGHT. SO, THE IMPLANTED AND THE EXPLANTED LINER HAVE THE SAME HEIGHT.

  Patient problems: Joint Laxity

  MAUDE report 14191711 ↗
• InjuryMay 4, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 1 YEAR AND 2 MONTHS AFTER PRIMARY DUE TO THE LIGAMENTS STRETCHING OUT. NO TRAUMATIC EVENT. THE SURGEON REPLACED THE 14 MM INSERT WITH A 20 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7486991 ↗
• InjuryNov 17, 2017Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 7040116 ↗
• InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING SWELLING. THE SURGEON DETERMINED THAT A HEMOTOMA HAD DEVELOPED CAUSING THE SWELLING. THE SURGEON PERFORMED A REVISION REPLACING THE 14MM SIZE POLY WITH A 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma; Joint Swelling

  MAUDE report 7008639 ↗