GMK Hinge Total Knee System 02.09.2603LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030825439), received between Mar 9, 2018 and Mar 2, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME REPORTING KNEE PAIN AND INSTABILITY. A BONE SCAN REVEALED THAT, IN THE GMK HINGE SYSTEM, BOTH THE TIBIAL AND FEMORAL COMPONENTS WERE LOOSE, WHILE THE STEMS APPEARED WELL FIXED. THE SURGEON DISASSOCIATED THE STEMS FROM THE FEMORAL AND TIBIAL COMPONENTS IN SITU AND REVISED BOTH THE FEMUR AND TIBIA. TO RECOUPLE THE NEWLY REVISED FEMUR, THE SURGEON ADDED AN OFFSET TO THE STEM LEFT IN THE BODY. THE TIBIA WAS RECOUPLED TO THE ORIGINAL STEM WITHOUT THE USE OF AN OFFSET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON DID NOT FOLLOW THE CORRECT PROCEDURE FOR THE GMK HINGE SYSTEM. THE SURGEON WAS REMINDED OF THE PROPER INDICATIONS FOR USE AND THE CORRECT SURGICAL TECHNIQUE FOR THE GMK HINGE SYSTEM AND PROVIDED THEM WITH THE IFU AND SURGICAL TECHNIQUE DOCUMENTATION.

  Patient problems: Implant Pain

  MAUDE report 24481879 ↗
• InjuryJun 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IN THE SAME DAY AFTER THE KNEE SURGERY PERFORMED ON THE (B)(6) 2024, A POST-OP PERIPROSTHETIC BONE FRACTURE WAS OBSERVED. A FOLLOW UP VISIT WAS DONE ON THE (B)(6) 2024. ACCORDING TO THE REVISION SURGEON, THE CAUSES OF THE POSTOPERATIVE FRACTURE WERE THE PATIENT'S OSTEOPOROSIS AND FRAGILITY OF THE ANTERIOR FEMORAL CORTEX, EXACERBATED BY A FALSE ROUTE DURING REAMING. THE IMPLANTS WERE NOT INVOLVED AT THIS STAGE. REVISION OF FEMORAL COMPONENT AND EXTENSION STEM PERFORMED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19614851 ↗
• InjuryDec 20, 2021Detachment of Device or Device Component

  ABOUT 2 MONTHS AFTER THE PREVIOUS REVISION SURGERY(PREVIOUSLY ALL IMPLANTS WERE REVISED DUE TO THE TIBIA TENDON HAD COME OFF), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13042794 ↗
• InjurySep 23, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12517862 ↗
• InjuryMar 9, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE PATIENT FRACTURED HER FEMUR. THE CAUSE OF THE FRACTURE IS UNKNOWN. TRAUMA WAS NOT REPORTED. THE SURGEON REVISED THE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7327060 ↗

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