GMK Hinge Total Knee System 02.09.2606RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030825507), received between Aug 18, 2017 and Nov 10, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT HAD PRIMARY KNEE SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PATELLA TRACKING ISSUES AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED (B)(4)). PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME REPORTING PAIN DUE TO PATELLA TRACKING ISSUES AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, INSERT, OFFSET, AUGMENTS, AND EXTENSION STEM. NATURAL PATELLA WAS KEPT. THE SURGERY WAS COMPLETED SUCCESSFULLY

  Patient problems: Implant Pain

  MAUDE report 23510650 ↗
• InjuryDec 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR KNEE INFECTION AT 2 YEARS AND 10 MONTHS FROM PRIMARY FOR KNEE INFECTION. ALL DEVICES WERE REVISED SUCCESSFULLY AND AN ANTIBIOTIC SPACER WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18316676 ↗
• InjuryJan 4, 2021Material Integrity Problem; Material Integrity Problem

  THE PATIENT CAME IN, 1 YEAR AND 3 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN AND INSTABILITY. X-RAYS REVEALED A FRACTURED CEMENT MANTLE PROXIMAL TO THE FEMORAL STEM EXTENSION AND LOOSE FEMORAL COMPONENTS. THE CAUSE OF THE FRACTURED CEMENT MANTLE AND THE LOOSE FEMORAL COMPONENTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11106981 ↗
• MalfunctionFeb 6, 2019Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  DURING THE PRIMARY KNEE SURGERY, IT WAS DISCOVERED THAT THE SIZE 6 FEMORAL COMPONENT PACKAGING (BLISTER AND BOX) WAS DAMAGED AND THE STERILITY WAS COMPROMISED. THERE WAS NOT ANOTHER SIZE 6 FEMORAL COMPONENT AVAILABLE AND THE SURGEON HAD TO USE A SIZE 5 INSTEAD. THIS CAUSED AN HOUR AND A HALF DELAY IN THE CASE, ANYWAY THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310183 ↗
• MalfunctionMar 16, 2018Packaging Problem

  WHEN OPENING THE IMPLANT, IT WAS NOTICED THAT THE INNER PACKAGING WAS COMPROMISED. THE AGENT HAD A SECONDARY IMPLANT, THE PACKAGING WAS DAMAGED. THE SURGEON DECIDED TO DOWN SIZE TO A SIZE 5, THE PACKAGING ON THIS IMPLANT WAS ALSO DAMAGED. THE AGENT HAD THE CLOSEST SALES REPRESENTATIVE TO DRIVE ANOTHER IMPLANT TO THE HOSPITAL. THIS IMPLANT WAS USED TO COMPLETE THE SURGERY. THERE WAS A SEVERAL HOUR DELAY IN THE CASE. IT WAS A 10 HOURS CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345189 ↗
• MalfunctionAug 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DURING FINAL IMPLANT ASSEMBLY, A DOUBLE PUNCTURE WAS FOUND IN THE PACKAGING OF THE SIZE 6 RIGHT GMK-HINGE FEMORAL COMPONENT. BOTH THE INTERNAL AND EXTERNAL PLASTIC PILL WERE CRACKED. THE TYVEK WAS NOT COMPROMISED. THE STERILITY WAS COMPROMISED. THE IMPLANT WAS REWASHED AND THEN AUTOCLAVED. THE TOTAL TIME DELAY WAS IN EXCESS OF 3 HOURS. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 6803629 ↗

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