GMK Sphere Total Knee System 02.12.0024LRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07630030862397), received between Jun 7, 2018 and Nov 21, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 reports).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT, FEMUR, AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23615703 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO YEARS AND FOUR MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN RELATED TO HYPEREXTENSION, THE CAUSE OF WHICH IS UNKNOWN. THE SURGEON REVISED THE FEMORAL, TIBIAL, AND INSERT COMPONENTS FROM GMK-SPHERE TO GMK-REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23461662 ↗
• InjuryFeb 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION PERFORMED DUE TO INFECTION ABOUT 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY. ALL COMPONENTS REVISED AND HINGE SYSTEM IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21320669 ↗
• InjuryNov 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20746292 ↗
• InjurySep 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL THE COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20117922 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR INFECTION AT ABOUT 3 YEARS AND 3 MONTHS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN. ON THE 2 DECEMBER 2023 WE WERE INFORMED THAT THE ANTIBIOTIC SPACER WAS REMOVED ON THE (B)(6) 2023 AND PERMANENT IMPLANTS WERE PUT IN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18099117 ↗
• InjuryJan 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2022, THE PATIENT HAD THE PRIMARY SURGERY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023. THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16223189 ↗
• InjuryJan 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

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

  MAUDE report 16157352 ↗
• InjuryMar 15, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 4 YEARS AND 1 MONTH AFTER PRIMARY, REVISION SURGERY FOR TIBIA AND FEMUR IMPLANTS LOOSENING. FEMUR, TIBIAL TRAY AND LINER REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 13770426 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND PAIN DUE TO A TORN PATELLA TENDON. THE PATHOGEN IS UNKNOWN AND THE REASON FOR THE TORN PATELLA TENDON IS UNKNOWN. AT 23 DAYS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED A ROD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Crushing Injury; Unspecified Infection

  MAUDE report 13365853 ↗
• InjuryJan 11, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 1 MONTH DUE TO TIBIAL AND FEMORAL COMPONENT LOOSENING. THE SURGEON COMMENTED THAT NO CEMENT WAS ATTACHED TO FEMORAL AND TIBIAL IMPLANTS IMPLANTED IN PRIMARY SURGERY AND THAT IMPLANT FIXATION IS POOR. ALL COMPONENTS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 13222353 ↗
• InjuryMay 6, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT HAD BECOME LOOSE LATERALLY (FEMUR WAS MOBILIZED) AND WAS UNSTABLE. THE CAUSE OF THE LOOSENESS AND INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT, AND ADDED A FLUTED EXTENSION STEM AS WELL AS A FEMORAL WEDGE 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11782829 ↗
• InjuryApr 8, 2021Unstable

  THE PATIENT CAME IN 2 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT, AND ADDED AN EXTENSION STEM AND FEMORAL DISTAL WEDGE.

  Patient problems: Insufficient Information

  MAUDE report 11633971 ↗
• InjuryNov 24, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT 1 YEAR AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 10895742 ↗
• InjuryJun 25, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO AN INFECTION (PATHOGEN UNKNOWN). ALL IMPLANTS REPORTED WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 10194903 ↗
• InjuryMar 12, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AFTER ABOUT 1 YEAR FROM THE PRIMARY SURGERY, THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON PLANS TO RESURFACE THE PATELLA AND REVISE THE FEMORAL COMPONENT. THE SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020.

  Patient problems: Pain

  MAUDE report 9822921 ↗
• InjuryJan 21, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 10 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE, PERFORMED A WASHOUT AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9610264 ↗
• InjurySep 27, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 2 MONTHS FROM THE LAST REVISION (B)(4) DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER SUCCESSFULLY. ON SEPT 28 THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9128596 ↗
• InjuryMar 18, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ABOUT 2 YEARS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8428914 ↗
• InjuryOct 5, 2018Device Dislodged or Dislocated

  ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR PATELLA DISLOCATION. THE SURGEON REVISED THE FEMUR COMPONENT WHICH ALLOWED THE PATELLA TO RELOCATE AND TRACK PROPERLY.

  Patient problems: Joint Disorder

  MAUDE report 7938072 ↗
• InjuryJun 7, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO SEPSIS ABOUT 3 MONTHS AFTER PRIMARY. THE SURGEON INSERTED ANTIBIOTIC SPACERS.

  Patient problems: Unspecified Infection

  MAUDE report 7578035 ↗