GMK Primary Total Knee System 02.07.1202RRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 07630030819872), received between Aug 3, 2017 and Aug 13, 2026 — classified as 60 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (17 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 61 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Revision surgery after 2 years and 8 months from the primary due to pain.The surgeon revised the tibial tray, insert, femoral component, and patella from GMK-Sphere to GMK-Revision. The surgery was completed successfully.

  Patient problems: Implant Pain

  MAUDE report 50232825 ↗
• InjuryJul 22, 2026Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED 1 MONTH AND HALF AFTER THE PRIMARY DUE TO INFECTION. THE SURGEON REMOVED ALL IMPLANTS AND PLACED ANTIBIOTIC SPACER. DURING THE PRIMARY SURGICAL PROCEDURE THE MEDACTA REPRESENTATIVE EXPERIENCED A MEDICAL EVENT, LOST CONSCIOUSNESS, AND FELL INTO THE OPEN SURGICAL FIELD ON THE SURGICAL DRAPS BEFORE COLLAPSING ONTO THE FLOOR. FOLLOWING THE EVENT, THE SURGEON INITIATED THE DISINFECTION PROTOCOL DUE TO THE POTENTIAL CONTAMINATION RISK OF THE SURGICAL SITE.

  Patient problems: Medical device site infection

  MAUDE report 25904707 ↗
• InjuryJul 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2025. APPROXIMATELY ONE YEAR AFTER SURGERY, THE PATIENT EXPERIENCED PAIN IN THE JOINT, AND X-RAYS CONFIRMED TIBIAL LOOSENING. A REVISION SURGERY IS SCHEDULED FOR (B)(6), 2026.

  Patient problems: Aseptic loosening

  MAUDE report 25747736 ↗
• InjuryJun 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO TIBIAL TRAY LOOSENING AFTER ABOUT 10 YEARS AND 1 MONTH FROM PRIMARY.

  Patient problems: Aseptic loosening

  MAUDE report 25607907 ↗
• InjuryMay 28, 2026Implant subsidence

  REVISION SURGERY DUE TO TIBIAL TRAY SUBSIDENCE AFTER ABOUT 1 YEAR AND 2 MONTHS FROM PRIMARY. THE SURGEON REVISED THE CEMENTED S2 TIBIAL TRAY TO A FIXED TINBN COATED SIZE 2 TIBIAL TRAY, REVISED THE FLEX 2R - 11MM INSERT TO A FLEX 2R - 10MM INSERT, REVISED THE S3+R CEMENTED FEMORAL COMPONENT TO A S3+R CEMENTED TINBN FEMORAL COMPONENT, AND REVISED THE MOTO ECROSS D 29 TO A SAME SIZE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25313930 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY IN FLEXION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS FROM GMK-SPHERIKA COMPONENTS TO GMK-REVISION COMPONENTS, EXCEPT THE PATELLA. THE 10MM LINER WAS REVISED TO A SEMI-CONSTRAINED 17MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24494896 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT FROM GMK-SPHERE TO GMK-REVISION. THE SURGEON ALSO REVISED THE PATELLA TO A SAME SIZE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 24454901 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  AT4 YEARS 1 MONTH 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: Implant Pain; Joint Laxity

  MAUDE report 24004375 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILTY DUE TOLIMITED EXTENSION AND FLEXION. THE SURGEON REVISED THE TIBIAL TRAY TO REVISION AND UPSIZED THE LINER (FROM 11 MM TO 12MM) AND IMPLANTED TIBIAL AUGMENTS. THE SURGERY WAS COMPLETED SUCCESFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23655143 ↗
• InjuryNov 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PAIN DUE TO A LOOSE TIBIA AND FEMUR IMPLANTS. AT ABOUT 6 YEARS POST PRIMARY THE SURGEON REVISED THE TIBIA, INSERT, AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. LACK OF ADHERENCE TO CEMENT FOUND. NON MEDACTA CEMENT WAS USED DURING PRIMARY.

  Patient problems: Aseptic loosening

  MAUDE report 23583097 ↗
• InjuryAug 6, 2025Implant subsidence; Implant subsidence

  4 YEARS AFTER THE PRIMARY PROCEDURE, THE PATIENT REPORTED PAIN CAUSED BY TIBIAL COMPONENT SUBSIDENCE. THE EVENT WAS LIKELY RELATED TO POOR BONE QUALITY AND EXCESSIVE BODY WEIGHT. THE SURGEON REVISED ALL COMPONENTS USING REVISION IMPLANTS. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 22725446 ↗
• InjuryMay 19, 2025Migration; Migration

  AT ABOUT 2 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING TIBIAL SUBSIDENCE WHICH CAUSED SUBSEQUENT TIBIAL LOOSENING CAUSED BY TRANSPORTING HEAVY LOADS. SURGEON REVISED ALL THE COMPONENTS SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22042951 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS. REHABILITATION HAS BEEN PERFORMED IN ORDER TO RESTORE THE JOINT MOBILITY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21932364 ↗
• InjuryDec 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PAIN AND WAS UNABLE TO FULLY EXTEND THEIR KNEE. HE DIDN'T LISTEN/FOLLOW RECOVERY INSTRUCTIONS AFTER SURGERY. AT ABOUT 8 MONTHS POST PRIMARY THE SURGEON DECIDED TO REVISE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT FROM A GMK SPHERIKA TO A GMK HINGE. IT IS UNKNOWN WHY THE SURGEON DECIDED TO REVISE EVERYTHING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 20900788 ↗
• InjuryOct 16, 2024Migration; Migration

  REVISION SURGERY PERFORMED DUE TO TIBIAL SUBSIDENCE. THE GMK-SPHERE TIBIAL TRAY SIZE 2 IMPLANTED DURING PRIMARY WAS UNDERSIZED. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A GMK REVISION TIBIAL TRAY SIZE 3 WITH EXTENSION STEM WERE SUCCESSFULLY IMPLANTED. PRIMARY SURGERY DATE UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460603 ↗
• InjurySep 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED DUE TO FEMORAL AND TIBIAL TRAY MOBILIZATION. ALL IMPLANTS REVISED SUCCESSFULLY TO COMPETITOR'S SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154931 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 2 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19071420 ↗
• InjuryApr 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19069665 ↗
• InjuryApr 9, 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, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL COMPONENT. THE CAUSE OF THE LOOSE TIBIAL COMPONENT IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND FEMUR TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19069663 ↗
• InjuryFeb 29, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED FOR TIBIAL TRAY SUBSIDENCE. A SEMI-CONSTRAINT (GMK REVISION) WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18805802 ↗
• InjuryFeb 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 5 YEARS AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND TIBIAL COMPONENT LOOSEING. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT (FROM 12 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18765738 ↗
• InjuryNov 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, TIBIAL TRAY AND INSERT REVISED DUE TO TIBIAL TRAY LOOSENING.

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

  MAUDE report 18063840 ↗
• InjurySep 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND DISCOMFORT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR, INSERT AND TIBIAL TRAY WITH REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ANY ISSUE WITH THE IMPLANTS DETECTED.

  Patient problems: Pain

  MAUDE report 17823868 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY DUE TO FLEXION DEFAULT.

  Patient problems: Joint Laxity

  MAUDE report 17670075 ↗
• InjuryJul 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS FROM THE PRIMARY, REVISION SURGERY DUE TO CEMENTED TIBIAL PLATE LOOSENING. THE SURGEON REVISED THE TIBIAL TRAY AND THE INSERT (FROM 12 TO 13 MM). TIBIAL COMPONENTS REVISED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17412888 ↗

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