GMK Sphere Total Knee System 02.12.0022LRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630030862472), received between Oct 30, 2018 and May 13, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Malposition of Device

  AT ABOUT 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY THAT WAS DETERMINED TO BE DUE TO THE PRIMARY FEMORAL COMPONENT NOT BEING EXTERNALLY ROTATED ADEQUATELY, WHICH WAS CAUSING PAIN ALONG THE PATELLA TENDON. THE SURGEON OBSERVED THAT THE JOINT WAS A COUPLE OF DEGREES OF RECURVATUM. THE SURGEON REVISED THE 13MM INSERT TO A SEMICONSTRAINED 23MM INSERT, REVISED THE S2+ FEMUR TO A REV. P.S. CEMENTED S3 FEMUR, AND RESURFACED THE PATIENT`S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25160334 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INSUFFICIENT FLEXION AND EXTENSION AFTER TOTAL PROSTHESIS AT 1 YEAR AND 8 MONTHS POST PRIMARY. THE POSTERIOR CAPSULE WAS MANUALLY RELEASED TO INCREASE FLEXION. THE TIBIAL COMPONENT WAS NOT REVISED. FEMORAL COMPONENT REVISED TO ONE OF THE SAME SIZE, SPHERE COMPONENT WITH A 4 MM INCREASED DISTAL CUT. INLAY REVISED WITH THE SAME SIZE AND HEIGHT: STABLE PROTHESIS AND SUFFICIENT FLEXION AND EXTENSION.

  Patient problems: Loss of Range of Motion

  MAUDE report 25148964 ↗
• InjuryAug 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO NICKEL ALLERGY ABOUT 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY. HINGE SYSTEM SENSITIN IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19936764 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INFECTION AT ABOUT 10 MONTHS FROM PRIMARY SURGERY. ALL DEVICES WERE REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16618608 ↗
• InjurySep 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 9 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, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15408758 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 15247648 ↗
• InjuryJul 6, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING STIFFNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. AT ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. FEMUR WAS REVISED BECAUSE THE SURGEON THOUGHT THE PATIENT FELL INTO THE VALGUS PHENOTYPE AND WANTED TO USE A SPHERIKA FEMUR.

  Patient problems: Loss of Range of Motion

  MAUDE report 14927427 ↗
• InjuryApr 1, 2022Appropriate Device Problem Term/Code Not Available

  THE FEMORAL COMPONENT AND THE INLAY HAVE BEEN REVISED 4 MONTHS AFTER PRIMARY, BECAUSE THE PATIENT WAS NOT ABLE TO FLEX THE KNEE AND WAS NOT STABLE IN EXTENSION. THE FEMUR WAS CHANGED FROM A 2+ INTO A 1+ AND THE LINER FROM 10MM TO 12MM.

  Patient problems: Loss of Range of Motion

  MAUDE report 13976490 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem

  5 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY A REVISION SURGERY WAS PERFORMED DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, MADE A SPACER OUT OF A MEDACTA FEMUR AND INSERT, AND APPLIED ANTIBIOTIC CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 5 MONTHS AFTER THE SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED THE EXISTING SPACER, AND IMPLANTED A NEW ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12438433 ↗
• InjuryJun 7, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND SWELLING IN THE KNEE. THE SURGEON DETERMINED THAT THE PATIENT HAD A METAL ALLERGY. THE SURGEON ALSO OBSERVED THAT ALL OF THE IMPLANTS WERE LOOSE AND THE CAUSE OF THE LOOSE IMPLANTS ARE UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND REVISED THEM WITH NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 11946158 ↗
• InjuryMay 26, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING TIGHTNESS DUE TO THE PRESENCE OF SCAR TISSUE. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT 4 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Discomfort; Scar Tissue

  MAUDE report 11884446 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. WHEN THE PATIENT CAME TO THE HOSPITAL ON (B)(6) 2020, THE SURGEON DISCOVERED THE INFECTION. THE SURGEON ONCE REMOVED THE IMPLANTS FROM THE PATIENT'S BODY AND INSERTED THE CEMENT MOLD SPACER ON (B)(6) 2020. REVISION SURGERY WILL BE PLANNED WITH THE COMPETITOR'S DEVICE AFTER THE FOLLOWING UP.

  Patient problems: Unspecified Infection

  MAUDE report 10867712 ↗
• InjuryNov 17, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN, ONE YEAR AND 6 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO LOOSE IMPLANTS. THE CAUSE OF LOOSE IMPLANTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, INSERT, AND ADDED AN OFFSET CONNECTOR, AND 2 EXTENSION STEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10850270 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 4 MONTHS AFTER PREVIOUS REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS ESCHERICHIA COLI. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10822492 ↗
• InjuryFeb 12, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO RUPTURED PATELLAR TENDON. FOR THE SURGEON THE EVENT IS DUE TO FEMUR CUT PERFORMED IN PRIMARY SURGERY. 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATELLA WAS FROM COMPETITOR.

  Patient problems: Bone Fracture(s)

  MAUDE report 9698768 ↗
• InjuryJun 13, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 4 MONTHS FROM THE PRIMARY DUE TO MID-FLEXION INSTABILITY. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8695292 ↗
• InjuryOct 30, 2018Insufficient Device Problem Information

  THE PATIENT HAD A FIRST REVISION SURGERY 3 MONTHS AFTER PRIMARY: THE POLY WAS SWAPPED AND THE PATELLA WAS RESURFACED [COMPLAINT (B)(4)]. NOW, 5 MONTHS AFTER PRIMARY SURGERY, A SECOND REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8019264 ↗