GMK Sphere Total Knee System 02.12.0411FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07630030862601), received between Aug 18, 2017 and Aug 6, 2025 — classified as 24 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS 4 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 22726217 ↗
• InjuryJun 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION FOR KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19465945 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 9 MONTHS AFTER PRIMARY, THE SURGEON REVISED THE INSERT WITH A THICKER ONE (FROM 11 TO 13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18191307 ↗
• InjuryAug 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 SUCCESSFULLY THE LINER.

  Patient problems: Medical device site infection

  MAUDE report 17570816 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY (FROM 11 MM TO 14 MM).

  Patient problems: Joint Laxity

  MAUDE report 17315592 ↗
• InjuryMay 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17001451 ↗
• InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS HE 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 16731991 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 MONTH FROM PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16583372 ↗
• InjuryJul 15, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT WITH A THICKER ONE TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED GMK-SPHERE TIBIAL INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15027950 ↗
• InjuryJan 25, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 11MM POLY WITH A 17MM POLY 2 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13342906 ↗
• InjuryDec 10, 2021Break

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND POST-OP X-RAYS INDICATED THAT THE POLY HAD DISENGAGED FROM THE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT 11 MONTHS AFTER PRIMARY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE LINER SCREW WAS NOT USED IN PRIMARY SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12975553 ↗
• InjuryFeb 24, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY 10 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE TIBIAL INSERT FIXED SPHERE FLEX #4/11 MM L WITH A SPHERE TIBIAL INSERT - FLEX S4L 14 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11372951 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 9MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 11MM S4 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11235030 ↗
• InjuryOct 1, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 YEARS AND 3 MONTHS AFTER PREVIOUS REVISION SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10612479 ↗
• InjuryAug 10, 2020Unstable; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY 9 MONTHS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, PATELLA, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FEMORAL COMPONENT AND PATELLA WERE NOT MOBILIZED, THE NEW LINER IS 12MM.

  Patient problems: Joint Disorder

  MAUDE report 10384112 ↗
• InjuryMar 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND 2 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9834573 ↗
• InjuryNov 13, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 24 DAYS AFTER THE PRIMARY DUE TO WOUND DEHISCENCE. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND INSERTED ANTIBIOTIC BEADS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Wound Dehiscence

  MAUDE report 9314362 ↗
• InjuryJul 9, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, MORE THAN ONE YEAR AFTER PRIMARY SURGERY, COMPLAINING OF MID FLEXION INSTABILITY. THE SURGEON REVISED A 11MM POLY WITH A 14MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8770629 ↗
• InjuryApr 25, 2019Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN, 8 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 11MM POLY WITH A 13MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8548593 ↗
• InjuryMar 11, 2019Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 10 MONTHS AFTER PRIMARY SURGERY AND THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 11MM POLY WITH A 17MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8408123 ↗
• InjuryJan 2, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN DUE TO INSTABILITY CAUSED BY THE SCREW BACKING OUT OF THE POLY. THE TORQUE LIMITING DRIVER WAS NOT USED IN THE PRIMARY SURGERY. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8208001 ↗
• InjuryMay 8, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 1 YEAR AND 1 MONTH AFTER PRIMARY. THE PATIENT STRETCHED OUT HIS KNEE THROUGH REHAB. THE SURGEON SWAPPED THE 10MM POLY FOR A 12MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7494714 ↗
• InjuryMay 3, 2018Unintended Movement

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE SCREW BACKED OUT OF THE SPHERE POLY. THE TORQUE DRIVER WAS NOT USED IN THE PRIMARY SURGERY. THE SURGEON REVISE THE SCREW ON (B)(6) 2018.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7483274 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON WASHED OUT THE KNEE AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6803617 ↗