GMK Hinge Total Knee System 02.09.2605RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030825484), received between Nov 17, 2017 and May 13, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Fracture

  REVISION SURGERY DUE TO A FRACTURED FEMUR AFTER ABOUT 2 MONTHS FROM PRIMARY AND THE CAUSE IS UNKNOWN. THE WAS NO INDICATION OF TRAUMA, BUT THE SURGEON DID NOTE POOR BONE QUALITY. THE SURGEON REVISED GMK-HINGE SIZE 5 FEMORAL COMPONENT TO A SAME SIZE FEMORAL COMPONENT AND REVISED THE GMK-HINGE 12MM INSERT TO A GMK-HINGE 14MM INSERT DUE TO LAXITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 25160348 ↗
• InjuryMay 11, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY 2 YEARS AFTER THE PRIMARY DUE TO FEMORAL COMPONENT LOOSENING. FEMORAL COMPONENT AND TIBIAL LINER SUCCESSFULLY REVISED.

  Patient problems: Insufficient Information

  MAUDE report 11805150 ↗
• InjuryJul 28, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017. ON (B)(6) 2018, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. PRESENTLY, ON (B)(6) 2020 (2 YEARS AND 8 MONTHS AFTER PRIMARY), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS PSEUDOMONAS. THE SURGEON PLANNED TO PERFORM A POLY-SWAP, BUT NOTICED DURING SURGERY THAT THE FEMORAL COMPONENT WAS LOOSE. THE SURGEON PERFORMED A POLY-SWAP AND EXTRACTED AND REPLACED WITH A HINGE FEMORAL COMPONENT WITH A STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10331333 ↗
• MalfunctionApr 1, 2020Break

  THE PATIENT CAME IN REPORTING PAIN AFTER FEELING A POP IN HIS KNEE. THE SURGEON DETERMINED THAT THE PATIENT'S FEMUR HAD BROKEN 2 YEARS AND 9 MONTHS AFTER PRIMARY. THERE IS NO REVISION SCHEDULED AT THIS TIME. WE DON'T KNOW IF REVISION SURGERY WILL BE PERFORMED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9909608 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 7 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. THE DATE IN WHICH THE SPACER WAS IMPLANTED IS UNKNOWN. THE SURGEON IMPLANTED PERMANENT HARDWARE ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 7788798 ↗
• InjuryNov 17, 2017Appropriate Device Problem Term/Code Not Available

  PROSTHESIS WAS EXPLANTED DUE TO A REPEAT INFECTION. THE COMPLETE PROSTHESES HAS BEEN EXPLANTED AND A CEMENT SPACER WITH ANTIBIOTIC HAS BEEN PUT IN. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7040106 ↗

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