GMK Primary Total Knee System 02.07.1202LRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 07630030819865), received between Oct 18, 2017 and Aug 3, 2026 — classified as 49 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  At about 3 years and 7 months from the primary, the patient came in reporing paindue to loosening of the tibial trayand the cause is unknown. The surgeon revised all components and the surgery was completed successfully.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 50114139 ↗
• InjuryJun 17, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO TIBIAL IMPLANT LOOSENING AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE TIBIAL TRAY AND THE INSERT FROM 10 MM TO 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Joint Laxity

  MAUDE report 25528759 ↗
• InjuryMay 20, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT 4 YEARS 10 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO TIBIA TRAY LOOSENING AND SUBSIDENCE. THE FEMORAL COMPONENT HAS TOO MUCH FLEXION. THE SURGEON IMPLANTED A COMPETITOR`S SYSTEM.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25230404 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF A METAL ALLERGY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERIKA TRAY TO A GMK-HINGE TRAY, THE GMK-SPHERIKA INSERT 13MM TO A GMK-HINGE 23MM INSERT, AND THE GMK-SPHERIKA FEMORAL COMPONENT TO A GMK-HINGE FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 24710827 ↗
• InjuryDec 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED AFTER 1 YEAR AND 7 MONTHS DUE TO TIBIAL AND PATELLAR LOOSENING. THE SURGEON USED A REVISION TIBIAL IMPLANT WITH AN EXTENSION STEM AND UPSIZED THE LINER DUE TO THE RECUT. ADDITIONALLY, THE PATELLA WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23837298 ↗
• InjuryOct 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AFTER 2 YEARS AND 6 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH LOOSENING OF THE TIBIAL TRAY. THERE WAS NO LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT WITH A GMK-REVISION TIBIAL TRAY WITH WEDGES, OFFSET, AND EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23299144 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22904219 ↗
• InjuryFeb 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Joint Laxity

  MAUDE report 21320668 ↗
• InjuryNov 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 9 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO TIBIA LOOSENING FOR A PATIENT INCLUDED IN A CLINICAL STUDY. ONLY TIBIAL COMPONENT REVISED.

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

  MAUDE report 20769967 ↗
• InjuryNov 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 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 IMPLANTED NEW PERMANENT PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20732325 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR ALLERGY AT ABOUT 3 YEARS POST PRIMARY. ANTIALLERGIC DEVICES IMPLANTED SUCCESSFULLY. THE PATIENT WAS SHOWING SIGNS OF A NICKEL SENSITIVITY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20704004 ↗
• InjuryOct 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON THE (B)(6) 2020, THE PATIENT UNDERWENT A PRIMARY SURGERY, WITH GMK-SPHERE COMPONENTS AND PATELLA RESURFACING IMPLANTATION. ON THE (B)(6) 2021, THE PATIENT CAME REPORTING PAIN AND INFECTION WAS DETECTED. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL INSERT. PRESENTLY, ON THE (B)(6) 2024, THE PATIENT CAME REPORTING PAIN AND LOOSENING OF THE TIBIAL TRAY WAS DETECTED. DURING THE REVISION SURGERY ALSO PATELLA IMPLANT LOOSENING WAS NOTICED. THE SURGEON REVISED SUCCESSFULLY ALL THE GMK-SPHERE COMPONENTS AND IMPLANTED GMK-REVISION SYSTEM WITH A NEW PATELLA IMPLANT.

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

  MAUDE report 20514138 ↗
• InjuryOct 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 3 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20405714 ↗
• InjurySep 12, 2024Migration; Migration

  AT 4 YEARS AND 11 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO POSTERIOR TIBIAL TRAY SUBSIDENCE. NO REPORTED PROBLEMS WITH THE CONTRALATERAL SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20198556 ↗
• InjuryJul 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO FEMORAL AND TIBIAL COMPONENTS LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19836830 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 19664070 ↗
• InjuryJun 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 19457185 ↗
• InjuryDec 14, 2023Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL TRAY. ABOUT 2 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18324609 ↗
• InjuryJul 25, 2023Positioning Failure; Positioning Failure

  DURING THE PRIMARY KNEE SURGERY, WHEN THE SURGEON WAS IMPLANTING THE INSERT, IT WOULD NOT SEAT. THE SURGEON OPTED TO USE A MALLET AGAINST THE PLASTIC POLY. DURING THIS ATTEMPT TO SET THE POLY WITH THE MALLET, THE TIBIA ROTATED DISTALLY AND WAS KICKED OUT FROM THE KEEL WHICH PUNCTURED THE TIBIA RESULTING IN A TOTAL FRACTURE. THE SURGEON PUT A PLATE WITH NINE SCREWS AS WELL AS A 30 MM EXTENSION STEM FOR THE FRACTURE. THERE WAS A 10-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17387762 ↗
• InjuryJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A ABOUT 5 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL COMPONENT AND THE CAUSE OF THE SUBSIDED TIBIAL COMPONENT 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 17258163 ↗
• InjuryJun 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR CEMENTED TIBIAL TRAY LOOSENING, CAUSING KNEE INSTABILITY, 1 YEAR AND 8 MONTHS POST PRIMARY. TIBIAL TRAY AND LINER WERE REVISED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17161710 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY FOR KNEE STIFFNESS AND PATELLOFEMORAL PAIN. THE SURGEON REVISED ALL THE DEVICES SUCCESSFULLY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16458789 ↗
• InjurySep 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 MONTH AND 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15485483 ↗
• InjuryApr 21, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO AN INFECTION IN THE KNEE ABOUT 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. THE PROSTHESIS WAS REMOVED AND ANTIBIOTICS AND A SPACER WERE INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 14165807 ↗
• InjuryDec 15, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD SUFFERED FROM PAIN FOR ALMOST 1 YEAR, PRESENCE OF HEAVY METALS. REVISION SURGERY PERFORMED 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO NICKEL ALLERGY AND PROSTHETIC LOOSENING THAT HAD BEEN DETECTED AFTER SCINTIGRAPHIC IMAGING. TRICOMPARTMENTAL PROSTHESIS ON A DEFORMATION GREATER THAN 10 DEGREES IN THE FRONTAL PLANE. THE REVISION WENT WELL. ACCORDING TO THE SURGEON, THE LOOSENING WAS CAUSED BY THE ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain

  MAUDE report 13010046 ↗

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