GMK Sphere Total Knee System 02.12.0210FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07630030826139), received between Oct 12, 2017 and Apr 14, 2026 — classified as 40 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AT 2 WEEKS FROM THE PRIMARY. THE INSET WAS REVISED.

  Patient problems: Medical device site infection

  MAUDE report 24871686 ↗
• MalfunctionJul 23, 2025Difficult to Insert; Difficult to Insert

  FAILURE OF COUPLING OF THE 10 MM AND 11 MM INSERTS WITH THE TIBIAL TRAY. A 12[?]MM INSERT WAS FINALLY IMPLANTED. SURGERY WAS PROLONGED BY ABOUT 50 MINUTES. THE SURGERY CONCLUDED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573888 ↗
• InjuryJul 8, 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 3 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22434261 ↗
• InjuryMay 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 10 MONTHS 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19403572 ↗
• InjuryApr 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19059642 ↗
• InjuryApr 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT (FROM 10 MM TO 12 MM) THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19018320 ↗
• InjuryFeb 28, 2024Device 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 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18795921 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY, THE SURGEON REVISED THE POLY (IMPLANTING A 2 MM THICKER LINER) AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18370901 ↗
• InjuryDec 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 1 MONTH AND A HALF POST-PRIMARY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18301142 ↗
• InjuryJul 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER ONE YEAR AND TWO MONTHS FROM THE PRIMARY, THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO POOR PATELLA TRACKING AND LAXITY. THE SURGEON SWITCHED THE PATELLA IMPLANT AND UPSIZED THE TIBIAL LINER INSERTIN A 2MM THICKER LINER.

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

  MAUDE report 17360776 ↗
• InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 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 THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17254938 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO A FLEXION CONTRACTURE AND THE CAUSE OF THE FLEXION CONTRACTURE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 16960187 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING LIMITED RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 16635897 ↗
• InjuryJan 13, 2023Device 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 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16161989 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 15299795 ↗
• InjuryJul 20, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT HAS BEEN REVISED BECAUSE OF INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15063297 ↗
• InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 7 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 THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14942339 ↗
• InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A BONE TIBIAL PLATEAU FRACTURE AND THE CAUSE IS UNKNOWN. AFTER ALMOST 1 YEAR AND 6 MONTHS THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 14684575 ↗
• InjuryMay 5, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND IT WAS REVEALED THAT THE PATIENT SUSTAINED AN MCL INJURY. THE SURGEON DECIDED TO REVISE THE POLY WITH A HIGHER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s); Pain

  MAUDE report 14286872 ↗
• InjuryApr 11, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 YEARS AND 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14072203 ↗
• InjuryFeb 18, 2022Unstable; Appropriate Device Problem Term/Code Not Available

  AT 2 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY (10 MM TO 20 MM) AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13558595 ↗
• InjuryDec 6, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 7 YEARS 5 MONTHS THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA. IT WAS ALSO OBSERVED THAT THE SCREW HAD BACKED OUT OF THE POLY. THE REASON FOR THE LOOSE TIBIA AND THE LOOSE SCREW IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12932365 ↗
• InjuryNov 30, 2021Appropriate Device Problem Term/Code Not Available

  AT 3 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 THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12890126 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 12759589 ↗
• InjuryMay 25, 2021Insufficient Device Problem Information

  REVISION SURGERY PERFORMED 2 YEARS AFTER THE PRIMARY DUE TO A HYPEREXTENDED KNEE. THE CAUSE OF THE HYPEREXTENDED KNEE IS UNKNOWN. THE SURGEON SUCCESSFULLY REVISED THE 10MM INSERT FOR A 17MM INSERT.

  Patient problems: Joint Laxity

  MAUDE report 11876981 ↗