GMK Hinge Total Knee System 02.09.0314HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030825132), received between Sep 7, 2017 and Feb 6, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Migration

  THE PATIENT HAD PRIMARY LEFT KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD PAIN DUE TO AN MCL INJURY. AT ABOUT 1 YEAR AFTER THE PRIMARY, THE SURGEON CONVERTED THE PATIENT FROM A SPHERE KNEE TO A HINGE KNEE BY REVISING THE TIBIAL TRAY, INSERT AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE HINGE YOKE SCREW WAS INSERTED USING A MANUAL MEDACTA SCREWDRIVER AND FORCED INTO PLACE WITH A MALLET INSTEAD OF THE PRESCRIBED 6 NM TORQUE LIMITER. ON (B)(6) 2026, THE PATIENT PRESENTED DUE TO A GMK HINGE YOKE SCREW THAT HAD UNSCREWED, CAUSING KNEE INSTABILITY. THE SURGEON REVISED THE LINER, IMPLANTING A LINER OF THE SAME SIZE AND SCREWED THE YOKE SCREW WITH THE CORRECT TORQUE DRIVER. NO PROBLEMS WERE DETECTED ON THE OTHER IMPLANTS DURING THE REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276573 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21574226 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY (PRIMARY GMK-HINGE), DURING A FOLLOW-UP VISIT, X-RAYS WERE TAKEN AND A HYPEREXTENSION OF ABOUT 12 DEGREES WAS OBSERVED. PATIENT IS UNCOMFORTABLE AND UNABLE TO WALK PROPERLY. HE WILL NEED A REVISION SURGERY. ADDITIONAL INFO: MYKNEE CASE CODE: (B)(4). MYKNEE BLOCK WAS UTILIZED FOR THE TIBIAL RESECTION BUT NOT FOR THE FEMUR.

  Patient problems: Hyperextension

  MAUDE report 21525700 ↗
• InjuryJan 29, 2025Migration; Migration

  REVISION SURGERY DUE TO GMK HINGE POST SCREW UNSCREWING AND SUBSEQUENT MIGRATION AT 2 MONTHS AFTER PRIMARY. IT HAS BEEN OBSERVED THAT THE THREAD OF THE SCREW WAS DAMAGED. TORQUE LIMITER WAS USED. THE SURGEON REVISED THE INSERT SUCCESSFULLY.

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

  MAUDE report 21264315 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 MONTHS AFTER 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 18578852 ↗
• InjuryApr 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT 13 DAYS FROM THE PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16741306 ↗
• InjuryAug 2, 2022Break; Loose or Intermittent Connection

  LUXATION OF THE HINGE INLAY, WHEN THE PATIENT STOOD UP FROM A CHAIR. DURING THE REVISION, THE SCREW OF THE INLAY WAS BROKEN. THE SCREW OF THE HINGE MECHANISM WAS CORRECTLY FIXATED. REVISION SURGERY PERFORMED 3 MONTHS AFTER THE PRIMARY SURGERY; ONLY INSERT REVISED WITH A HIGHER ONE (FROM 14 MM TO 20 MM). A BIG LAXITY WAS OBSERVED DURING REVISION.

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

  MAUDE report 15147140 ↗
• InjuryJul 18, 2022Material Rupture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED EXTENSOR MECHANISM. THE SURGEON REPAIRED THE EXTENSOR MECHANISM AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s)

  MAUDE report 15040192 ↗
• InjuryJul 30, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, 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 8841138 ↗
• InjuryApr 19, 2018Microbial Contamination of Device

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AND TWO WEEKS AFTER PRIMARY. THE PATHOGEN IS UNAVAILABLE. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7442494 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6847606 ↗

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