GMK Hinge Total Knee System 02.09.0514HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030825279), received between Jun 15, 2018 and Aug 3, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Revision surgery due to infection after 21 days from primary. The surgeon performed a washout, removed all implants, and implanted a competitor femoral nail.

  Patient problems: Medical device site infection

  MAUDE report 50114133 ↗
• InjuryAug 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 6 MONTHS FROM 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; Unspecified Infection

  MAUDE report 20019599 ↗
• InjuryApr 4, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19040019 ↗
• InjuryMar 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 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 HAD COMPETITOR COMPONENTS BEFORE MEDACTA COMPONENTS.

  Patient problems: Medical device site infection

  MAUDE report 18817502 ↗
• InjuryJan 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER MEDACTA 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. PRIMARY SURGERY WAS WITH COMPETITOR COMPONENTS. DURING REVISION OF THE COMPETITOR'S IMPLANTS, MEDACTA HINGE COMPONENTS WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18502390 ↗
• InjuryMay 3, 2019Fracture; Fracture

  ON THE (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY PLANNED AND PERFORMED ON THE (B)(6) 2019. THE REVISION SURGERY WAS TWO MONTHS AFTER THE PRIMARY DUE TO THE POST SCREW BREAKAGE. THE SCREW WAS FOUND OUTSIDE THE IMPLANT CAUSING PAIN TO THE PATIENT. REVISION SURGERY COMPLETED SUCCESSFULLY (INSERT REVISION).

  Patient problems: Pain

  MAUDE report 8577871 ↗
• InjuryApr 4, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A HEMATOMA 8 DAYS AFTER PRIMARY. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 8482795 ↗
• InjuryJun 15, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AND 5 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR INLAY SCREW UNSCREWING. THE SURGEON SWAPPED SUCCESSFULLY THE INLAY SCREW.

  Patient problems: No Code Available

  MAUDE report 7605412 ↗

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