GMK Hinge Total Knee System 02.09.0412HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030825194), received between Jun 15, 2018 and May 13, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS TO ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25160341 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2019, THE PATIENT WAS REVISED FROM THE COMPETITOR IMPLANTS TO MEDACTA IMPLANTS. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO INSTABILITY AS A RESULT OF THE LOOSENING IMPLANTS OF THE TIBIA AND FEMUR, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-REVISION FEMUR, TRAY, AND INSERT TO A GMK-HINGE FEMUR, TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR (B)(4). PRESENTLY, ON (B)(4) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-HINGE LINER TO A GMK-HINGE LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454896 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 5 WEEKS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23694045 ↗
• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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

  MAUDE report 21355650 ↗
• InjuryMar 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER AND HINGE POST EXTENSION.

  Patient problems: Medical device site infection

  MAUDE report 18957341 ↗
• InjuryMay 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17031355 ↗
• InjuryAug 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15299797 ↗
• MalfunctionJul 14, 2021Break; Break

  BREAKAGE OF THE POST SCREW IMPLANTED IN (B)(6) 2020. THE PRIMARY WITH COMPETITOR IMPLANTS WAS PERFORMED IN 2007. IN 2020 THE PATIENT HAD TWO REVISION SURGERIES, IN (B)(6) 2020 (COMPETITOR IMPLANTS WERE EXPLANTED AND MEDACTA HINGE KNEE IMPLANTED DUE TO INFECTION) AND IN (B)(6) 2020 (A LINER REVISION WAS PERFORMED DUE TO INFECTION). AT THIS MOMENT THE REVISION SURGERY IS NOT PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 12165055 ↗
• InjurySep 22, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 22 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10566036 ↗
• InjuryDec 4, 2019Material Integrity Problem; Material Integrity Problem

  REVISION SURGERY PERFORMED DUE TO POST SCREW UNSCREWING AND PIVOT DISENGAGEMENT FROM THE HINGE MORE THAN 2 YEARS FROM THE PRIMARY SURGERY. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE INLAY LOCKING SCREW WAS BROKEN. THE SURGEON ONLY REVISED THE 12 MM INLAY WITH A 17 MM INLAY, IT WAS NOT POSSIBLE TO USE A NEW INLAY LOCKING SCREW BECAUSE A PART OF THE BROKEN SCREW REMAINED IN THE TIBIAL TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9410175 ↗
• InjuryOct 24, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 18 DAYS AFTER THE PRIMARY DUE TO PAIN DUE TO A HEMATOMA IN THE KNEE. THE CAUSE OF THE HEMATOMA IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND INLAY SWAP SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 9232329 ↗
• InjuryJun 15, 2018Break; Device Slipped; Unstable

  REVISION SURGERY PERFORMED DUE TO POST SCREW UNSCREWING 3 MONTHS AFTER PRIMARY, DURING THE REVISION SURGERY ALSO THE INLAY LOCKING SCREW WAS FOUND LOOSE IN THE JOINT AND BROKEN. THE PATIENT WAS OPERATED AT THE BEGINNING FOR SEVERE GENU RECURVATUM AND WAS VERY GOOD AFTER SURGERY WITH RETURN TO FULL FUNCTION. IN (B)(6) 2018, THE PATIENT CAME TO HOSPITAL DUE TO PAIN AND INSTABILITY, THE X-RAYS SHOWED A COMPLETE DISSOCIATION OF THE FEMUR FROM THE TIBIA AND THE POST LOCKING SCREW DISENGAGEMENT. DURING THE REVISION SURGERY THE POLY LOCKING SCREW WAS ALSO FOUND BROKEN, MACROSCOPIC EXAM REVILED WEAR OF THE POLY ON ITS ANTERIOR PORTION, THE LINER WAS REVISED.

  Patient problems: Pain

  MAUDE report 7605649 ↗

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