GMK Primary Total Knee System 02.07.1203RRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 07630030819896), received between Nov 9, 2017 and Jul 16, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (16 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 16, 2026Implant subsidence

  REVISION SURGERY DUE TO TIBIAL SUBSIDENCE AFTER ABOUT 5 YEARS AND 4 MONTHS FROM PRIMARY. THE SURGEON REVISED TIBIAL TRAY AND INSERT. THE PATIENT HAD A FIRST REVISION SURGERY ON (B)(6) 2023 WHERE THE SURGEON REVISED THE FEMORAL COMPONENT AND TIBIAL INSERT (MDR 3005180920-2023-00515)-

  Patient problems: Implant Pain

  MAUDE report 25838727 ↗
• InjuryMay 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO TIBIAL LOOSENING AFTER ABOUT 1 YEAR AND 5 MONTHS FROM PRIMARY SURGERY. THERE ARE NO INDICATIONS OF TRAUMA OR POOR BONE QUALITY. THE SURGEON OBSERVED THAT THE FEMUR AND PATELLA WERE NOT LOOSE. THE SURGEON REVISED THE 11MM INSERT TO A 12MM INSERT AND REVISED THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25077219 ↗
• InjuryDec 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIAL TRAY, INSERT FROM GMK-SPHERIKA TO GMK-REVISION. THE SURGEON ALSO SWAPPED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23876945 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AS THE RESULT OF A PERIPROSTHETIC FRACTURE OF THE PROXIMAL TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE TIBIAL TRAY, INSERT, AND EXTENSION STEM AND IMPLANTED A INSERT, TIBIAL TRAY, EXTENSION STEM, AND TIBIAL AUGMENTED SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23858467 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALMOST 1 YEAR AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO FLEXION IMBALANCE AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THAT A FLEXION IMBALANCE WOULDN'T BE CORRECTED BY A POLY SWAP OR UPSIZING, SO ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY, HE REVISED TO A HINGE SYSTEM TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PCL (POSTERIOR CRUCIATE LIGAMENT) WAS SACRIFICED AT THE PRIMARY SURGERY AND THE SURGEON THINKS THAT THIS CAUSED THE FLEXION IMBALANCE.

  Patient problems: Joint Laxity

  MAUDE report 23310527 ↗
• InjuryAug 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22726922 ↗
• InjuryJun 25, 2025Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 6 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE TIBIAL COMPONENTS FAILED INTO VARUS. UPON REVISING THE PATIENT, THE SURGEON ALSO OBSERVED THAT THE FEMORAL COMPONENT WAS LOOSE. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22328100 ↗
• InjuryMay 30, 2025Osseointegration Problem; Osseointegration Problem

  AT 6 YEARS 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND TIBIAL COMPONENT. THE FEMUR WAS PROBABLY OVERSIZED. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22114522 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, 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 22096080 ↗
• InjuryMar 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL PRIMARY COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21709058 ↗
• InjuryMar 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A METAL SENSITIVITY AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS TO ANTIALLERGIC COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21662619 ↗
• InjuryFeb 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21311193 ↗
• InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. ABOUT 7 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE TIBIA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20396225 ↗
• InjurySep 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED ABOUT 2 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO TIBIAL AND FEMORAL COMPONENTS MOBILIZATION. ALL IMPLANTS REVISED TO GMK-REVISION SYSTEM.

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

  MAUDE report 20222620 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19749505 ↗
• InjuryNov 16, 2023Malposition of Device; Malposition of Device

  AT ABOUT 3 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE PATIENT HAD ONLY 80-90 DEGREES OF FLEXION AND THE SURGEON CONCLUDED THAT THE TIBIA WAS NOT CUT WITH ENOUGH POSTERIOR SLOPE. THE SURGEON PERFORMED A NEW CUT TO CORRECT THE SLOPE (3 TO 6 +/- 1 DEGREE) AND REVISED THE INSERT AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18146681 ↗
• InjurySep 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 MONTH FROM THE PRIMARY, REVISION SURGERY DUE TO TIBIA LOOSENING. NO KNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 17763774 ↗
• InjuryJul 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A MALROTATED TIBIA AND THE CAUSE IS UNKNOWN. AT ABOUT 11 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT AND TIBIA AS WELL AS INTERNALLY ROTATED THE TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17315836 ↗
• InjuryJun 22, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A NICKEL ALLERGY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS TO HINGE SENSITIN COMPONENTS AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17181878 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT 1 YEAR AND 7 MONTHS POST PRIMARY DUE TO INSTABILITY EXPERIENCED BY THE PATIENT DURING KNEE FLEXION. ALL DEVICES REVISED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16544211 ↗
• InjuryJan 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 6 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT HAD AN INSTABILITY OF THE RIGHT KNEE. THE SURGEON TRIED TO INCREASE THE INLAY TO RESTORE THE REQUIRED STABILITY. HE DIDN´T ACHIEVE THIS STABILITY AND REVISED ALSO THE FEMUR AND TIBIA.

  Patient problems: Joint Laxity

  MAUDE report 16240592 ↗
• InjuryOct 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15679058 ↗
• InjuryAug 3, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ASEPTIC LOOSENING OF A GMK SPHERE SYSTEM 1 YEAR 10 MONTHS AFTER THE PRIMARY. DURING THE REVISION IT WAS NOTED THAT THE TIBIAL COMPONENT AND THE FEMORAL COMPONENT WERE LOOSE AND HAD NO CEMENT. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 15154691 ↗
• InjuryAug 2, 2022Malposition of Device; Malposition of Device

  A RIGHT TKA REVISION OCCURED ON (B)(6) 2022 DUE TO AN ERROR MADE BY THE USER AT THE PRIMARY SURGERY DONE ON (B)(6) 2022. AFTER THE PRIMARY TKA DONE ON THE PATIENT, THE PO X-RAYS REVEALED A POOR POSITIONING OF THE KNEE IMPLANTS BY THE SURGEON. THE ERROR WAS DUE TO THE FACT THAT THE PATIENT HAD A VALGIZATION OSTEOTOMY AT HER RIGHT KNEE 20 YEARS AGO, WHICH CAUSED A CHANGE IN THE PATIENT'S RIGHT KNEE ANATOMY.

  Patient problems: Insufficient Information

  MAUDE report 15146773 ↗
• InjuryJul 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY, FEMORAL COMPONENT AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 15025734 ↗

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