GMK Hinge Total Knee System 02.09.0512HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030825262), received between Sep 14, 2018 and Dec 24, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY RIGHT KNEE SURGERY WITH A COMPETITOR ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED TO A MEDACTA HINGE KNEE ON (B)(6) 2025 FOR AN UNKNOWN REASON. PRESENTLY, ON (B)(6) 2025 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HINGE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23886585 ↗
• InjuryFeb 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 8 DAYS FROM THE PREVIOUS SURGERY, 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 21313000 ↗
• InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 20555080 ↗
• InjuryJul 27, 2023Fracture; Fracture

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON 1 (B)(6) 2022,THE PATIENT REPORTED PAIN AND LAXITY. THE PCL (POSTERIOR CRUCIATE LIGAMENT) AND MCL (MEDIAL COLLATERAL LIGAMENT) WERE FOUND TO BE COMPROMISED, THEREFORE THE SURGEON DECIDED TO REVISE THE FEMORAL COMPONENT AND THE LINER TO SWITCH TO A CONSTRAINED PROSTHESIS. ON (B)(6) 2022, THE PATIENT CAME IN SHOWING SIGNS OF INSTABILITY AND DISLOCATION DUE TO A COMPROMISED MCL. THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND IMPLANT A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME TO THE ER REPORTING PAIN AND THE FEELING OF A LOOSE BODY IN THE KNEE. UPON REVIEWING X-RAYS, THE SURGEON DETERMINED THAT POST SCREW WAS BROKEN AND A NEW ONE NEEDED TO BE IMPLANTED. 6 NM TORQUE LIMITER WAS USED FOR THE POST SCREW INSERTION. THE SURGEON REVISED THE LINER AND RETRIEVED ALL FRAGMENTS. A NEW LINER (WITH A NEW POST) HAS BEEN IMPLANTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17403982 ↗
• InjurySep 14, 2018Break; Break

  WE WERE INFORMED ON 17 AUGUST 2018 THAT A PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON BELIEVES THE POLY IS LOOSE. THE SURGEON PLANS TO REVISE ON (B)(6) 2018. MORE INFORMATION TO FOLLOW THE CASE. UPDATE 21 AUGUST 2018: ON (B)(6) 2018, DURING SURGERY, THE SURGEON DETERMINED THAT THE POLY FIXATION SCREW BROKE. THE SURGEON LEFT EVERYTHING AS IS, THE SCREW WAS NOT RETRIEVED.

  Patient problems: Pain

  MAUDE report 7876591 ↗

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