GMK Primary Total Knee System 02.07.1206RRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030819957), received between Jun 15, 2018 and May 29, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 8 YEARS AND 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO LOOSENING OF THE TIBIAL IMPLANT. THE SURGEON ELECTED TO REMOVE ALL MEDACTA PRODUCTS AND REVISE THE PATIENT WITH COMPETITOR IMPLANTS.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 25328460 ↗
• InjuryMay 25, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION DUE TO TIBIAL TRAY LOOSENING ABOUT 8 YEARS AND 6 MONTHS AFTER PRIMARY. NO LOOSENING OF THE FEMORAL COMPONENT. NO INFECTION. EXPLANTATION OF THE TIBIAL TRAY AND INSERT. REIMPLANTATION OF A GMK-REVISION TIBIAL TRAY WITH WEDGES, OFFSET AND EXTENSION STEM.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25268617 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO TIBIAL LOOSENING SECONDARY TO PERIPROSTHETIC FRACTURE AT ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY. PRESENCE OF A PARTICULAR TISSUE UNDER THE TIBIAL TRAY WITH POOR BONE QUALITY. EXPLANTATION OF TIBIAL TRAY AND INSERT.

  Patient problems: Bone Fracture(s)

  MAUDE report 24020872 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE DUE TO THE DEVELOPMENT OF SCAR TISSUE. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON CLEANED OUT THE SCAR TISSUE AND REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 22008319 ↗
• InjuryApr 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21771570 ↗
• InjuryOct 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20405452 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 18648766 ↗
• InjuryApr 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE TIBIA AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16769101 ↗
• InjuryNov 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PRIMARY TKR WAS DONE ON (B)(6) 2018. THE SURGEON NOTICED THE TIBIAL TRAY WAS LOOSE AFTER INVESTIGATING THE PATIENTS X-RAYS. THE PATIENT COULD NOT BE SCHEDULED FOR SURGERY DUE TO WORKING RESPONSIBILITIES. THE PATIENT FELL A FEW MONTHS AFTER THE CONSULTATION. THE SURGEON RE-EVALUATED THE X-RAYS AND NOTICED THE TIBIAL TRAY WAS COMPLETELY LOOSE. SCHEDULED A REVISION SURGERY WITH (B)(6). THE FEMORAL COMPARTMENT DID NOT SHOW SIGNS OF LOOSENING. DURING THE REVISION THE SURGEON NOTICED THE FEMORAL COMPARTMENT WAS COMPLETELY LOOSE AND HE WAS ABLE TO REMOVE IT BY HAND. NO CEMENT WAS PRESENT ON THE IMPLANTS.

  Patient problems: Pain

  MAUDE report 15752030 ↗
• InjuryJun 15, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14698599 ↗
• InjuryMay 3, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT 6 MONTHS FROM PRIMARY DUE TO TIBIAL TRAY FIXED CEMENTED LOOSENING. TIBIAL TRAY AND LINER SWAPPED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 14268869 ↗
• InjuryApr 29, 2022Loosening of Implant Not Related to Bone-Ingrowth

  ANTERIOR PAIN DESCRIBED BY THE PATIENT. PATELLA NECROSIS. NO INFECTION BUT LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. AT 4 YEARS AND 8 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL THE COMPONENTS AND RESURFACED THE PATELLA BONE. THE SYSTEM WAS CHANGED FROM GMK-SPHERE IMPLANTS TO GMK-HINGE; THAT'S THE REASON FOR AN INSERT CHANGING.

  Patient problems: Necrosis; Pain

  MAUDE report 14250758 ↗
• InjuryDec 17, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAT PAIN AND CONTRACTURES ON THE KNEE, SO THE SURGEON DECIDED TO CHANGE THE INLAY AND EVENTUALLY TO CHANGE THE TIBIA SIZE TO ONE SMALLER. DURING SURGERY FEMUR COMPONENT AND TIBIA COMPONENT WERE LOOSE AND CAME OUT REALLY EASILY. NO CEMENT WAS STUCKED TO THE PROSTHESIS. EVERYTHING WAS REVISED 1 YEAR AFTER PRIMARY. TEH SUREGEON SAWED BOTH THE FEMORAL AND TIBIAL BONE IN ORDER TO REMOVE THE CEMENT (SINCE ALL THE CEMENT WAS ATTACHED TO THE BONE). AS A RESULT THERE WAS BONE LOSE AND A HIGHER INLAY WAS NECESSARY TO COMPENSATE. IT IS UNKNOWN IF PAIN AND CONTRACTURE ARE RELATED TO THE MOBILIZATION OF THE PROSTHESIS. THE CONTRACTURE, ON THE OTHER HAND, IS LINKED TO THE FACT THAT THE KNEE WAS VERY TIGHT AND THE SCAR WAS VERY EXTENSIVE AND VERY THICK.

  Patient problems: Joint Contracture; Pain

  MAUDE report 11028064 ↗
• InjuryFeb 14, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY THAT WILL BE PERFORMED, 4 MONTHS AFTER THE PRIMARY SURGERY, DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9710733 ↗
• InjuryJun 15, 2018Loose or Intermittent Connection

  ABOUT 2 YEARS AFTER PRIMARY THE PATIENT WAS REVISED FOR TIBIAL LOOSENING. TIBIAL COMPONENTS SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7605436 ↗

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