GMK Sphere Total Knee System 02.12.0022RRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030862366), received between Aug 25, 2017 and Jan 10, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Positioning Failure; Positioning Failure

  THE TRIAL FITTED INTO THE PATIENT'S PREPARED FEMUR WITHOUT ANY PROBLEMS, BUT THE IMPLANT WITH CEMENT DID NOT FIT (LOT 2346925). THE SURGEON TRIED TO HAMMER THE IMPLANT, BUT THERE WAS A GAP OF 5 - 6MM, SO THE SURGEON REMOVED IT. THE SURGEON ATTEMPTED TO INSERT A SECOND FEMUR OF THE SAME REFERENCE BUT DIFFERENT LOT (2412734) BUT HE WAS NOT ABLE TO FIT IT IN ON THE FEMUR. SO THE SURGEON MADE AN ADDITIONAL CUT BY FREE HAND IN THE FEMUR, RECEMENTED AND PLACED THE SECOND USED FEMUR TESTED BEFORE (2412734). THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DELAY TIME WAS 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122125 ↗
• InjuryOct 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 5 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20493338 ↗
• InjuryMay 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 6 YEARS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19389764 ↗
• InjurySep 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AFTER THE 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 15484039 ↗
• InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available

  AT 3 YEARS AND 11 MONTHS POST PRIMARY REVISION SURGERY FOR KNEE INSTABILITY. THE REASON OF INSTABILITY IS UNKNOWN. ALL COMPONENTS HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14101037 ↗
• InjuryDec 10, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  AT 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LOOSE LIGAMENTS THE CAUSE OF THE LOOSE LIGAMENTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT.

  Patient problems: Joint Laxity

  MAUDE report 12974187 ↗
• InjuryDec 19, 2019Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT FELL DOWN ON NOV 24. THEN THE SURGEON DISCOVERED THAT THE PROSTHESIS SUBLUXATED, IT IS UNKNOWN IF THE REASON FOR SUBLUXATION IS THE FALL OR IF THE PROSTHESIS SUBLUXED BEFORE. REVISION SURGERY PERFORMED SUCCESSFULLY, 5 WEEKS AFTER PRIMARY SURGERY, AND GMK HINGE HAS BEEN IMPLANTED. NO CEMENT WAS FOUND ON THE EXPLANTS. THE TIBIA HAS BEEN REMOVED WITHOUT ANY DIFFICULTY DESPITE THE CEMENTATION WAS PERFORMED CORRECTLY DURING PRIMARY SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 9494689 ↗
• InjuryJul 4, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 5 MONTHS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR A INFECTION. THE PATIENT HAD A SEPTIC ARTHRITIS. FEMUR, TIBIA AND INSERT REVISED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8762570 ↗
• InjuryJul 4, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED SUCCESSFULLY 7 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY.

  Patient problems: Joint Disorder

  MAUDE report 8762568 ↗
• InjuryFeb 26, 2019Unstable

  THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY INSTABILITY 4 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8370491 ↗
• InjuryApr 12, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN 9 MONTHS AFTER PRIMARY: SHE HAD A FLEXION CONTRACTURE. THE SURGEON REVISED ALL HARDWARE EXCEPT THE PATELLA AND IMPLANTED A PS SYSTEM.

  Patient problems: Joint Disorder

  MAUDE report 7425010 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information

  AFTER THE PRIMARY SURGERY, THE PATIENT ALLEGED THE PAIN. X-RAYS WAS TAKEN SEVERAL DAYS AFTER AND FOUND THE BONE FRACTURE. HOSPITALIZATION WAS PROLONGED.

  Patient problems: Bone Fracture(s)

  MAUDE report 6819955 ↗