GMK Hinge Total Knee System 02.09.0117HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030825002), received between Nov 10, 2017 and Aug 3, 2026 — classified as 4 injuries, 1 malfunction.

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

• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Revision surgery after 5 days from the last surgery due to infection. The surgeon performed a washout and a second-stage poly swap to a poly of the same size. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50114120 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Revision surgery after 1 year and 11 months from the Medacta primary due to infection. The surgeon revised the insert to the same size insert.

  Patient problems: Medical device site infection

  MAUDE report 50005842 ↗
• InjuryJun 17, 2020Break; Break

  THE PATIENT COMPLAINED KNEE INSTABILITY. 3 YEARS AND 4 MOTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT KNEE FINDING THE INLAY SCREW BROKEN (LINER FIXATION SCREW). ONLY THE LINER WAS SWAPPED DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10161717 ↗
• InjuryApr 26, 2019Unstable; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED 2 MONTHS FORM THE PRIMARY DUE TO INSTABILITY CAUSED BY THE SETSCREW AND YOLK BECOMING DISASSOCIATED WITH THE AXEL PIN OF THE HINGE INSERT. THE SURGEON REVISED THE 17MM INSERT WITH A 23MM INSERT. THE SURGEON WAS ABLE TO SEAT THE MORSE TAPER ON THE AXLE PIN AND THE SETSCREW WAS REPOSITIONED AND TORQUED USING THE TORQUE-LIMITING DRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8555113 ↗
• MalfunctionNov 10, 2017Device Issue; Device Issue

  THE PATIENT ORIGINALLY CAME IN DUE TO A CLICKING NOISE IN HER KNEE. THE SURGEON DETERMINED THE SCREW HAD BACKED OUT OF THE YOKE. THE SURGEON PERFORMED A POLY SWAP. THERE WAS NO DAMAGE TO THE SCREW OR THE YOKE. THE SURGEON THREADED THE SCREW BACK INTO THE YOKE. IT WENT IN WITH NO ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 7018030 ↗

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