GMK Primary Total Knee System 02.07.1203LRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 07630030819889), received between Jul 13, 2017 and Jul 14, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (15 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 5 YEARS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING ASEPTIC LOOSENING OF THE TIBIA AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA OR A FALL. THE SURGEON REVISED THE GMK-SPHERE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT TO GMK-HINGE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25813729 ↗
• InjuryJan 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT1 YEAR AND 7 MONTHS FROM THE PRIMARY SURGERY, THEPATIENT PRESENTED WITH PAIN CAUSED BY A LOOSE BASEPLATE DUE TO POOR BONE QUALITY. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24004373 ↗
• InjuryDec 18, 2025Malposition of Device; Malposition of Device

  AT ABOUT 8 MONTHS FROM THE PRIMARY WAS PERFORMED A TOTAL KNEE REVISION DUE TO MALPOSITION OF THE TIBIA. EXCESSIVE EXTERNAL ROTATION. THE SURGEON DECIDED TO REMOVE EVERYTHING AND IMPLANT A SEMI-CONSTRAINED PROSTHESIS.

  Patient problems: Joint Laxity

  MAUDE report 23838592 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT2 YEARS 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TRAY, FEMUR AND INSERT TO A GMK-REVISION SYSTEM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23579774 ↗
• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  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 21354881 ↗
• InjuryJul 3, 2024Migration; Migration

  REVISION SURGERY DUE TO TIBIAL TRAY FIXED CEMENTED SUBSIDENCE, AT ABOUT 2 MONTHS AFTER PRIMARY.

  Patient problems: Pain

  MAUDE report 19665065 ↗
• InjuryJul 3, 2024Migration; Migration

  AT 3 YEARS AND 6 MONTHS FROM 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 THE TIBIAL TRAY, FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19664069 ↗
• InjuryJun 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 11 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19573513 ↗
• InjuryJun 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 3 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19517347 ↗
• InjuryJan 15, 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 REVISION COMPONENTS AND THE SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18510520 ↗
• InjuryJan 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450738 ↗
• InjuryNov 24, 2023Migration; Migration

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT REPORTED THAT WAS NOT ABLE TO WALK PROPERLY. FROM THE X-RAYS IT WAS NOTICED A SUBSIDENCE OF THE TIBIAL TRAY, LEAVING TO A VARUS CONDITION. THE REVISION WAS SUCCESSFULLY COMPLETED BY IMPLANTING A REVISION TIBIAL TRAY OF THE SAME SIZE ALONG WITH A STEM AND TIBIAL AUGMENT IN THE MEDIAL SIDE.

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

  MAUDE report 18204618 ↗
• InjuryJul 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 6 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA. THE SURGEON REVISED THE TIBIA, FEMUR AND INSERT AND IMPLANTED A REVISION TIBIA WITH A STEM AND A REVISION FEMUR WITH A STEM AS WELL AS A SEMICONSTRAINED INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17413268 ↗
• InjuryJun 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17190146 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 20 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN, DUE TO A FRACTURED TIBIA AND THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON PLATED THE FRACTURE AND NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17182006 ↗
• InjuryApr 17, 2023Migration; Migration

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO CEMENTED TIBIAL TRAY SUBSIDENCE AND CONSEQUENT TIBIAL TRAY LOOSENING. THE SURGEON REVISED TIBIAL TRAY AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751773 ↗
• InjuryApr 4, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 6 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS AS A RESULT OF CEMENT DEBONDING. THE CAUSE OF THE CEMENT DEBONDING IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16673074 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. AT ABOUT 2 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE TIBIAL TRAY, FEMORAL COMPONENT AND TIBIAL INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16146455 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT HAD TOO MUCH POSTERIOR SLOPE. AT ABOUT 3 WEEKS FROM PRIMARY, THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15832737 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AT 1 YEAR AND 5 MONTHS POST PRIMARY FOR PAIN AND KNEE INSTABILITY. THE SURGEON REVISED TIBIAL TRAY, INSERT AND FEMUR SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15526928 ↗
• InjuryJun 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT 5 YEARS FROM PRIMARY FOR TIBIAL TRAY LOOSENING THAT HAD SUBSIDED. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14694222 ↗
• InjuryMay 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 2 YEARS AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14336939 ↗
• InjuryApr 20, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE 17 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14157398 ↗
• InjuryApr 5, 2022Migration; Migration

  AT 9 YEARS AND 4 MONTHS AFTER PRIMARY, THE SURGEON REVISED THE TIBIAL TRAY FIXED CEMENTED FOR IMPLANT SUBSIDENCE. THE REASON OF SUBSIDENCE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14011545 ↗
• InjuryDec 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT 9 YEARS AND 1 MONTH AFTER PRIMARY DUE TO FEMUR AND TIBIAL IMPLANT MOBILIZATION. ALL IMPLANTS REVISED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13060403 ↗

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