GMK Hinge Total Knee System 02.09.0312HRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030825125), received between Jul 14, 2017 and May 12, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K130299); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY WITH COMPETITOR PRODUCTS AND WAS REVISED TO MEDACTA SPHERE ON (B)(6), 2023. ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING GLOBAL INSTABILITY IN THE RIGHT KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE FEMORAL AND CEMENTED TIBIAL COMPONENT TO A GMK-HINGE FEMORAL AND TIBIAL COMPONENT AND THE GMK-HINGE TIBIAL INSERT SIZE 4 - 10MM TO A SIZE 3 - 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 I&D AND REVISED THE INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148951 ↗
• InjuryOct 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGERY PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 23434016 ↗
• InjuryJun 4, 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: Medical device site infection

  MAUDE report 22140921 ↗
• InjuryApr 28, 2025Device 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 2 MONTHS 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 21917677 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY (PRIMARY GMK-HINGE), DURING A FOLLOW-UP VISIT, X-RAYS WERE TAKEN AND A HYPEREXTENSION OF ABOUT 10 DEGREES WAS OBSERVED. THE HYPEREXTENSION AFFECTS THE PATIENT'S GAIT PATTERN.

  Patient problems: Hyperextension

  MAUDE report 21525740 ↗
• InjuryApr 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19018522 ↗
• InjuryMar 1, 2024Migration; Migration

  THE POST SCREW HAD BACKED OUT OF THE POLY. AT 3 YEARS AND 8 MONTHS POST PRIMARY (GMK HINGE IMPLANTED DURING PRIMARY), THE SURGEON REVISED THE PATIENT BY REPLACING THE SCREW AND THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 18817511 ↗
• InjuryDec 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND 10 DAYS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18372073 ↗
• InjuryOct 12, 2023Fracture; Fracture

  ABOUT 4 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE INLAY LOCKING SCREW WAS FOUND BROKEN. REVISION PLANNED FOR (B)(6) 2024. THE PATIENT HAS A NEUROLOGICAL GAIT DISORDER AND IT IS SUSPECTED THAT THIS HAS RESULTED IN STRONG LEVER FORCES.

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

  MAUDE report 17919800 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS AFTER THE SYSTEM WAS IMPLANTED, 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 16582856 ↗
• InjuryDec 14, 2022Device 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 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15977604 ↗
• InjuryAug 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT'S MEDACTA PRIMARY SURGERY WAS A REVISON OF COMPETITOR COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 15319226 ↗
• InjuryJul 18, 2022Loose or Intermittent Connection; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  AT 1 WEEK FROM PRIMARY SURGERY THE SURGEON FOUND THE HINGE MECHANISM LOOSE, HINGE PIVOT INSIDE THE LINER, FEMUR DETACHED FROM PIVOT AND SCREW FREE IN THE JOINT. HE DID OPEN THE KNEE, INSERTED THE FEMUR IN THE PIVOT AND RE-TIGHTENED THE POST LOCKING SCREW (THE ONE LOOSE IN THE JOINT) COMPLETING THE SURGERY SUCCESSFULLY. THE POST SCREW WAS NOT SCREWED DURING THE PRIMARY DUE TO USER ERROR..

  Patient problems: Insufficient Information

  MAUDE report 15041335 ↗
• InjuryJul 21, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PATHOGEN IS UNKNOWN). ABOUT 6 MONTHS AFTER THE FIRST REVISION SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A PRIMARY WITH COMPETITOR IMPLANT, MEDACTA IMPLANT WAS IMPLANTED IN THE FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 12202385 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INFECTION 1 MONTH AFTER THE PRIMARY 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 11207400 ↗
• InjuryJul 14, 2017Break; Loose or Intermittent Connection

  REVISION SURGERY 16 MONTHS AFTER PRIMARY DUE TO BREAKAGE OF THE SCREW. THE SCREW WAS LOOSE IN THE JOINT. SURGEON REMOVED THE SCREW AND REPLACED THE INLAY, WITHOUT A SCREW. THE SURGEON WAS NOT QUITE HAPPY WITH THE SOLUTION, HE DID NOT WANT TO MAKE A TIBIA CHANGE.

  Patient problems: No Information

  MAUDE report 6714026 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130299. One submission often covers many models, so check the product and lot details in each record.

• Z-2661-2017 · May 19, 2017 · Terminated
  Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
• Z-0275-2016 · Apr 17, 2015 · Terminated
  GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery