GMK Sphere Total Knee System 02.12.0002RRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030825804), received between Apr 24, 2018 and Jun 7, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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.

• InjuryJun 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE PATIENT HAD AN ALLERGIC REACTION TO NICKEL. AT ABOUT 7 MONTHS POST PRIMARY THE SURGEON SWAPPED PRIMARY KNEE TO A SENSITIN REVISION KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19487718 ↗
• InjuryFeb 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR FEMORAL AND TIBIAL IMPLANT LOOSENING. AT ABOUT 2 YEARS FROM PRIMARY ALL DEVICES REVISED.

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

  MAUDE report 16435551 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16094456 ↗
• InjuryApr 28, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF TIBIA, FEMUR, AND PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14239391 ↗
• InjuryDec 20, 2021Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN IN THE KNEE AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13042191 ↗
• InjuryMay 25, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  3 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO THE LOOSENING OF IMPLANTS. THE CAUSE OF THE LOOSE IMPLANTS IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, THE FEMORAL COMPONENT, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11875982 ↗
• InjuryMay 4, 2021Structural Problem

  10 MONTHS AFTER PRIMARY THE PATIENT CAME IN REPORTING DISCOMFORT AND THE SURGEON OBSERVED THAT THE PATIENT HAD A FLEXION CONTRACTURE. THE CAUSE OF THE FLEXION CONTRACTURE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT AND ADDED A FLUTED EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 11769483 ↗
• InjuryDec 14, 2020Appropriate Device Problem Term/Code Not Available

  ADDITIONAL SURGERY PERFORMED 1 MONTH AFTER PRIMARY DUE TO FEMORAL CONDYLE FRACTURE. THE SURGEON FIXED THE FRACTURE WITH A LOCKING PLATE. THE PATIENT BONE WAS WEAK.

  Patient problems: Bone Fracture(s)

  MAUDE report 11001864 ↗
• InjuryFeb 26, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 2 YEARS AND 2 MONTHS AFTER THE PRIMARY DUE TO PATELLA PAIN AND FEMORAL COMPONENT ROTATION AND POSTERIOR-LATERAL CONDYLE DEFECT DUE TO A CYST (THE CYST DIDN'T CAUSE THE ROTATION). ALL IMPLANTS WERE REVISED.

  Patient problems: Joint Disorder

  MAUDE report 9757034 ↗
• InjuryNov 6, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE X-RAYS SHOWED THAT THE FEMORAL IMPLANT IN PLACE WAS TOO BIG FOR THE PATIENT BONE. THE PATIENT WAS REVISED 1 YEAR AFTER PRIMARY BECAUSE HAD ANTERIOR KNEE PAIN. FEMORAL COMPONENTS SWAP AND PATELLA RESURFACING PERFORMED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9284062 ↗
• MalfunctionSep 21, 2018Packaging Problem; Packaging Problem

  WHEN THE FEMORAL COMPONENT WAS OPENED, IT WAS NOTICED THAT THE INTERNAL PACKAGING WAS CRACKED. THE SURGEON USED A SECONDARY IMPLANT COMPLETING SUCCESSFULLY THE SURGERY.

  Patient problems: No Information

  MAUDE report 7897540 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON THAT THE PATIENT CAME IN COMPLAINING OF STIFFNESS. THE SURGEON PLANS TO REVISE THE PATIENT. ON (B)(6) 2018. THE INSERT WAS SWAPPED AS PLANNED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7453608 ↗