GMK Sphere Total Knee System 02.12.T3I4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07630030827136), received between Aug 3, 2017 and Mar 16, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  PRIMARY SURGERY PERFORMED ON THE (B)(6) 2020. IMPLANTATION OF GMK-SPHERE COMPONENTS WITHOUT PATELLA RESURFACING. FIRST REVISION SURGERY PERFORMED ON THE (B)(6) 2020 DUE TO ANTERIOR PAIN DESCRIBED BY THE PATIENT AND LAXITY OF THE KNEE. IMPLANTATION OF A RESURFACING PATELLA SIZE 2.THE 12MMLINER WAS REVISED WITHA 14MM LINER. SECOND REVISION SURGERY PERFORMED ON THE (B)(6) 2026.LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. NO INFECTION.EXPLANTATION OF THE FEMORAL AND TIBIAL COMPONENTS WITH LINER. REIMPLANTATION OF GMK-REVISION IMPLANTS WITH EXTENSION STEMS, OFFSETS AND WEDGES. EVENT ALSO RELATED TO (B)(4).

  Patient problems: Inadequate Osseointegration

  MAUDE report 24603553 ↗
• InjuryFeb 12, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT 3 YEARS 2 MONTHS, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL COMPONENT TO A GMK-REVISION COMPONENT AND REVISED THE INSERT FROM AN 11MM TO A 14MM SIZING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24321111 ↗
• InjuryOct 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  TWO YEARS AND EIGHT MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO TIBIAL LOOSENING. THE SURGEON REVISED THE FEMORAL, TIBIAL, AND INSERT COMPONENTS WITH TINBN-COATED IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23347369 ↗
• InjuryOct 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND TIBIAL TRAY LOOSENING HAS BEEN DETECTED. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY, INSERT AND RESURFACED THE NATURAL PATELLA.

  Patient problems: Pain

  MAUDE report 20462135 ↗
• InjuryJun 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19517343 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO PAIN PERFORMED ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY. DURING THE REVISION, IT WAS NOTED THAT THE CEMENT HAD NOT ADHERED TO THE FEMORAL AND TIBIAL COMPONENTS (CEMENT WAS NOT MEDACTA). ALL COMPONENTS REVISED TO GMK REVISION SYSTEM.

  Patient problems: Pain

  MAUDE report 19381857 ↗
• InjuryApr 12, 2024Migration; Migration

  AT ABOUT 4 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL BASEPLATE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19097610 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO KNEE INSTABILITY. THE SURGEON REVISED THE LINER (10 TO 14MM) WITH PATELLAR BONE RESURFACING.

  Patient problems: Joint Laxity

  MAUDE report 17867197 ↗
• InjuryJul 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS 9 MONTHS AFTER PRIMARY, REVISION SURGERY PERFORMED FOR CEMENTED TIBIAL TRAY LOOSENING. NO CEMENT ATTACHMENT OBSERVABLE ON THE COMPONENTS. THE SURGEON REVISED SUCCESSFULLY THE SYSTEM TO GMK HINGE SENSITIN AND RESURFACED THE PATIENT'S PATELLA BONE.

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

  MAUDE report 17256766 ↗
• InjuryApr 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT 3 YEARS AND 3 MONTHS POST PRIMARY DUE TO TIBIAL TRAY LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY, FIXED TIBIAL CEMENTED COMPONENT AND INSERT SWAPPED.

  Patient problems: Insufficient Information

  MAUDE report 16681951 ↗
• InjuryMar 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 6 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 PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16596971 ↗
• InjuryJul 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT ABOUT 1 YEAR FROM PRIMARY FOR CEMENTED TIBIAL TRAY LOOSENING. TIBIAL TRAY AND LINER REVISED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 15093771 ↗
• InjuryJul 21, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND FEMORAL COMPONENT. THE SURGEON REVISED THE TIBIAL TRAY, FEMORAL COMPONENT AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15072644 ↗
• InjuryJun 7, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOR KNEE INFECTION AT 1 YEAR AND 5 MONTHS AFTER PRIMARY. ALL COMPONENTS REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14621593 ↗
• InjuryApr 25, 2022Unstable

  REVISION SURGERY PERFORMED 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO INSTABILITY. DURING THE REVISION SURGERY, THE TIBIA WAS FOUND TO BE LOOSE. TIBIA REVISED AND HIGHER LINER IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 14191913 ↗
• InjuryMar 24, 2021Loosening of Implant Not Related to Bone-Ingrowth

  KNEE REVISION SURGERY 1 YEAR AND 2 MONTHS AFTER PRIMARY FOR PATIENT KNEE PAIN. THE PATIENT NEVER REPORTED INSTABILITY, ONLY PAIN. DURING THE REVISION SURGERY, IT WAS NOTICED THAT THE TIBIAL TRAY FIXED CEMENTED WAS LOOSE. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL COMPONENTS, INCREASED THE SIZE OF THE INSERT TO ADD MORE STABILITY AND CONSTRAINT, AND ADDED AN OFFSET CONNECTOR AND EXTENSION STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11562511 ↗
• InjuryMar 11, 2021Inadequacy of Device Shape and/or Size

  6 MONTHS AFTER PRIMARY SURGERY THE PATIENT HAD PAIN. POST-OP X-RAYS INDICATED THE TIBIAL TRAY WAS TOO LARGE AND WAS OVERHANGING ON THE LATERAL TIBIAL SIDE. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11462847 ↗
• InjuryFeb 11, 2020Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIA. THE CAUSE OF THE LOOSE TIBIA IS UNKNOWN. THE SURGEON REVISED THE MEDACTA TIBIAL TRAY FIXED CEMENTED # T3-I4 L WITH A MEDACTA REV. TIBIAL TRAY LEFT S3 AND A MEDACTA SPHERE INSERT FLEX LEFT 12MM S4 WITH A MEDACTA SPHERE INSERT FLEX LEFT 14MM S3 ALMOST 2 YEARS AND A HALF AFTER PRIMARY. THE SURGEON ALSO ADDED AUGMENTS AND AN EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9693710 ↗
• InjuryOct 24, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. ABOUT 1 YEAR AFTER PRIMARY THE SURGEON RESURFACED THE PATELLA BONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9233160 ↗
• InjurySep 19, 2019Loose or Intermittent Connection

  THE SURGEON HAS NOTIFIED THAT THE TIBIAL COMPONENT OF THE PATIENT IS LOOSE. REVISION PERFORMED ALMOST 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. WE WERE INFORMED ABOUT THE EVENT ON AUGUST 20, THE REVISION SURGERY HAS BEEN PERFORMED ON (B)(6).

  Patient problems: Joint Disorder

  MAUDE report 9086484 ↗
• InjuryJan 30, 2019Patient-Device Incompatibility

  THE PATIENT CAME IN 8 MONTHS AFTER PRIMARY SURGERY DUE TO PAIN. A POLY SWAP WAS PERFORMED (SEE MDR 2018-00786). NOW, 3 MONTH AND A HALF AFTER THE FIRST REVISION SURGERY, THE PATIENT CAME IN DUE TO INFECTION. THE SURGEON REVISED ALL THE IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8288676 ↗
• InjuryDec 7, 2018Unstable

  THE PATIENT CAME IN 1 YEAR AND 7 MONTHS AFTER PRIMARY SURGERY DUE TO INSTABILITY, CAUSED BY THE SUBSIDENCE OF THE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8141705 ↗
• InjurySep 21, 2018Loose or Intermittent Connection

  WE WERE INFORMED ON 23 AUGUST 2018 THAT A REVISION SURGERY IS NECESSARY DUE TO SUSPICION LOOSENING TIBIAL PLATEAU. THE REVISION PERFORMED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7897539 ↗
• InjurySep 14, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 1 YEAR AND 8 MONTHS AFTER PRIMARY DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON REVISED THE TIBIA AND INSERT.

  Patient problems: Joint Disorder

  MAUDE report 7876595 ↗
• InjuryMay 24, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A INFECTION. ALL THE DEVICE REPLACED SUCCESSFULLY AFTER A PERIOD WITH A SPACER IMPLANTED. PATHOGEN NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7540697 ↗