GMK Primary Total Knee System 02.07.1204RRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 07630030819919), received between Nov 9, 2017 and Aug 3, 2026 — classified as 64 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (22 reports).

1 other recall cover devices cleared under the same FDA submission (K090988); 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  At about 3 years 10 months after the primary, the patient came in reporting instability and the cause of the instability is unknown. The surgeon revised all components to GMK-hinge components and the surgery was completed successfully.

  Patient problems: Joint Laxity

  MAUDE report 50114132 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Revision surgery after 5 months from the primary due to infection. The surgeon revised all the components to match those of the competitor.

  Patient problems: Medical device site infection

  MAUDE report 50005872 ↗
• InjuryApr 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT REPORTED PAIN AND INSTABILITY. REVISION SURGERY WAS PERFORMED ABOUT 5 YEARS AFTER THE PRIMARY SURGERY DUE TO TIBIAL LOOSENING AND SUBSIDENCE ON THE MEDIAL SIDE, FULLY DETACHED FROM THE CEMENT MANTLE. FEMORAL COMPONENT CEMENTLESS SHOWED BONE RESORPTION AT THE MEDIAL DISTAL CUT AND AT THE SUPERIOR CHAMFER. BECAUSE THE TIBIAL PLATEAU COULD NOT BE EASILY EXPOSED FOR A PARTIAL REVISION, AND GIVEN THE RESORPTION AT THE FEMORAL COMPONENT, IT WAS DECIDED TO REVISE THE ENTIRE PROSTHESIS. ALL COMPONENTS REVISED AND SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25039773 ↗
• InjuryMar 31, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION 7 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE TIBIAL TRAY TO A SENSITIN TRAY, THE PATELLA TO A SAME SIZE PATELLA, THE INSERT FROM A 10MM TO AN 11MM AT THE SURGEON`S DISCRETION AND AND FEMORAL COMPONENT TO SAME SIZE SENSITIN FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24738814 ↗
• InjuryJan 23, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE PATELLA, TIBIAL TRAY, INSERT AND FEMORAL COMPONENT DUE TO THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24162756 ↗
• InjuryDec 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED TWO YEARS AFTER THE PRIMARY SURGERY DUE TO A LOOSE TIBIAL TRAY. ALL GMK SPHERE COMPONENTS WERE REVISED TO GMK REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23876948 ↗
• InjuryNov 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 4 YEARS 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, FEMUR, AND TIBIA TO GMK-REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23583073 ↗
• InjuryAug 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 8 MONTHS FROM PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22911356 ↗
• InjuryJul 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 9 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22664212 ↗
• InjuryJul 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  PRIMARY SURGERY PERFORMED ON (B)(6) 2018. IN (B)(6) 2025, X-RAYS WERE TAKE AND SUBSIDENCE AND MOBILIZATION WERE SUSPECTED. ON (B)(6) 2025, REVISION SURGERY WAS PERFORMED (ABOUT 7 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY): THE TIBIAL TRAY WAS SLIGHTLY LOOSE BUT STILL FIXED, WHILE THE FEMORAL COMPONENT WAS LOOSE AND COULD BE EASILY REMOVED. THE INSERT SHOWED MULTIPLE SCRATCHES AND YELLOW DISCOLORATION ON BOTH THE ARTICULATING AND BACKSIDE SURFACES. ALL IMPLANTS WERE REPLACED WITH COMPETITORS' REVISION-TYPE IMPLANTS (WITH EXTENSION STEMS), AND THE INSERT WAS ALSO REPLACED WITH A MORE CONSTRAINED TYPE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening

  MAUDE report 22564636 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 2 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE PATIENT TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22477786 ↗
• InjuryMay 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 5 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22084266 ↗
• InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT TWO WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22058684 ↗
• InjuryMar 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT ABOUT 8 MONTHS POST PRIMARY. THE PATIENT REPORTED LAXITY AND THE JOINT HAD LIQUID EFFUSION. NO IMPLANT LOOSENING FOUND DURING THE VISIT. LOOSENING OF THE TIBIAL COMPONENT FOUND DURING THE REVISION. NO INFECTION REPORTED. TIBIAL COMPONENTS REVISED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21705293 ↗
• InjuryMar 5, 2025Migration; Migration

  AT ABOUT 8 YEARS 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL COMPONENT. THE CAUSE OF THE SUBSIDED TIBIAL COMPONENT IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21523849 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO GMK-HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21364697 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20931516 ↗
• InjurySep 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM THE PRIMARY THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPCAER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 20300221 ↗
• InjurySep 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN, AND THE SURGEON SUSPECTED THAT FOREIGN BODIES WERE PRESENT IN THE BODY. THE SURGEON OPERATED ON THE PATIENT AND DID NOT DISCOVER ANYTHING BUT DECIDED TO PERFORM A WASHOUT AND POLY SWAP. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A TIBIAL FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE TIBIA AND POLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20117921 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN. REVISION SURGERY DUE TO TIBIAL IMPLANT LOOSENING AT 2 YEARS AND 8 MONTHS FROM THE PRIMARY. ALL PRIMARY IMPLANTS WERE REMOVED AND HINGE-SYSTEM SUCCESSFULLY IMPLANTED.

  Patient problems: Pain

  MAUDE report 20045699 ↗
• InjuryJun 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 3 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND RE-IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19573047 ↗
• InjuryJan 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 2 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO TIBIAL AND FEMORAL COMPONENTS LOOSENING. DURING THE SURGERY, IT WAS OBSERVED THAT THERE WAS NO CEMENT ON BOTH COMPONENTS AND THE LINER SEEMS TO BE DELAMINATED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18451505 ↗
• InjuryDec 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WAS REVISED AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY FOR TIBIAL TRAY LOOSENING. ALL THE IMPLANTS WERE EXCHANGED TO A COMPETITOR SEMI-CONSTRAINED SYSTEM. NO CEMENT FOUND UNDER THE TIBIAL IMPLANT.

  Patient problems: Pain

  MAUDE report 18383093 ↗
• InjuryDec 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO TIBIAL MOBILIZATION AT 1 YEAR AND 6 MONTHS FROM THE PRIMARY SURGERY. INSERT, TIBIAL AND FEMORAL COMPONENT SUCCESSFULLY REVISED WITH GMK REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18364408 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18256288 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090988. One submission often covers many models, so check the product and lot details in each record.

• Z-0266-2018 · Oct 24, 2017 · Terminated
  The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0