GMK Sphere Total Knee System 02.12.T3I4RRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07630030827143), received between Nov 15, 2018 and Jun 30, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Osseointegration Problem

  REVISION SURGERY DUE TO A LOOSE TIBIA AFTER ABOUT 10 YEARS AND 6 MONTHS FROM PRIMARY SURGERY. THE SURGEON REVISED THE CEMENTED S4 FEMUR TO A GMK-REVISION CEMENTED P.S. S4 FEMUR, REVISED THE CEMENTED FIXED T3-I4 TIBIAL TRAY TO A GMK-REVISION S3 TIBIAL TRAY, AND REVISED THE 14MM S4 INSERT TO A P.S. 10MM S3 INSERT.

  Patient problems: Aseptic loosening

  MAUDE report 25663309 ↗
• InjuryJan 13, 2026Malposition of Device

  REVISION SURGERY AFTER 8 MONTHS FROM THE PRIMARY DUE TO A MALPOSITIONED CEMENTED TIBIAL TRAY.THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24051151 ↗
• InjuryOct 29, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE TIBIA, MADE A 2 DEGREE VARUS RECUT, PLACED A STEM AND TIBIA PLATE WITH AN UPSIZED POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20554896 ↗
• InjuryJul 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PRIMARY SURGERY PERFORMED ON THE (B)(6) 2021. IMPLANTATION OF GMK-SPHERE IMPLANTS (TIBIAL TRAY T3I4 - TIBIAL INSERT 4 10MM - FEMORAL COMPONENT 4 (02.12.0004R / 2010165) - RESURFACING PATELLA 3). ON THE (B)(6) 2022, REVISION SURGERY PERFORMED FOR PATELLA LOOSENING. OSTEOPHYTE REMOVAL AND IMPLANTATION OF A NEW PATELLA 3. ON THE (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN. REVISION SURGERY PERFORMED FOR KNEE INSTABILITY ON THE LATERAL SIDE AND TIBIAL TRAY LOOSENING. NO LOOSENING OF THE FEMORAL COMPONENT. NO INFECTION. THE SURGEON REVISED THE TIBIAL TRAY, THE INSERT (FROM 10 MM TO 17 MM) AND USED AN EXTENSION STEM.

  Patient problems: Joint Laxity

  MAUDE report 19814523 ↗
• InjuryMar 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 2 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF TIBIAL COMPONENT LOOSENING. DURING THE SURGERY, IT WAS NOTICED THAT THE CEMENT WAS FIRMLY ATTACHED TO THE BONE AND NOT TO THE PROSTHESIS. THE FEMORAL COMPONENT WAS STILL ANCHORED TO THE BONE, BUT WAS EASILY REMOVED. THERE ARE ALSO SCRATCHES ON THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY IMPLANTING GMK HINGE SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 18892524 ↗
• InjuryJan 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR PAIN DUE TO LOOSENING OF THE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND RESURFACED THE NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18613587 ↗
• InjuryMar 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2022. ON (B)(6) 2022 THE LINER WAS REVISED DUE TO INFECTION (02.12.0414FR LOT. 1902504 REMOVED AND CR 02.12.0414CRR LOT. 1902542 IMPLANTED). ON (B)(6) 2023 ALL COMPONENTS WERE REVISED AND HINGE SYSTEM IMPLANTED. THE INFECTION WAS ALREADY HEALED, HOWEVER, THE KNEE WAS UNSTABLE (LIGAMENT LAXITY) DUE TO BONE QUALITY BECAUSE THE INFECTION CAUSED BONE RESORPTION.

  Patient problems: Unspecified Infection

  MAUDE report 16512787 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT. THE NEW IMPLANTS WILL BE USED AS A TEMPORARY ANTIBIOTIC SPACER AND THE PATIENT WILL HAVE PERMANENT HARDWARE IMPLANTED AT A LATER DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15040376 ↗
• InjuryMay 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 3 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO INSTABILITY ON THE MEDIAL PART AND LOOSENING OF THE TIBIAL PLATE. INSTABILITY OF THE KNEE WITH LAXITY ON THE MEDIAL PART AND LOOSENING OF THE TIBIAL PLATE. INSERT AND TIBIAL TRAY REVISED AND TIBIAL WEDGES AND EXTENSION STEM ADDED.

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

  MAUDE report 14336302 ↗
• InjuryApr 6, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT 3 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14021615 ↗
• InjuryJan 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 2 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13280911 ↗
• InjuryDec 16, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  AT 6 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LOOSE TIBIA. NO FRACTURE, NO INFECTION. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13017592 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem

  1 YEAR AND 5 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 COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12432335 ↗
• InjuryAug 31, 2021Loose or Intermittent Connection

  11 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN WAS UNKNOWN. THE SURGEON OPENED UP THE PATIENT AND OBSERVED THAT BOTH THE TIBIAL TRAY AND FEMORAL COMPONENT WERE LOOSE. THE CAUSE OF THE LOOSE IMPLANTS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12390638 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem

  3 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY FIRST STAGE REVISION TOTAL KNEE WAS DONE DUE TO DIAGNOSED (B)(6) INFECTION 4 YEARS AFTER THE PRIMARY PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 11973432 ↗
• InjuryMay 4, 2021Device Dislodged or Dislocated

  REVISION SURGERY 3 YEARS AND 3 MONTHS AFTER THE PRIMARY FOR TIBIAL PLATEAU SUBSIDENCE. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL COMPONENTS.

  Patient problems: Failure of Implant

  MAUDE report 11770222 ↗
• InjuryDec 18, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE AN ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON PLANNED TO REVISE THE TIBIAL COMPONENT AND POLY ON (B)(6) 2020, 2 YEARS AND 1 MONTH AFTER PRIMARY, BUT THE CASE HAD TO BE POSTPONED DUE TO THE PATIENT GOING INTO ATRIAL ATRIAL FIBRILLATION JUST PRIOR TO THE START OF THE CASE. REVISION SURGERY HAS NOT BEEN PERFORMED YET.

  Patient problems: Balance Problems

  MAUDE report 11037586 ↗
• InjuryNov 20, 2020Migration

  SECOND REVISION SURGERY PERFORMED AFTER 5 MONTHS FROM THE PREVIOUS REVISION SURGERY DUE TO THE MOBILIZATION OF THE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY, THE LINER AND THE PATELLA IMPLANT. DURING THE FIRST REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER FROM 12 MM(LOT 174808) TO 17 MM (LOT 154783) AND ADD THE PATELLA IMPLANT DUE TO KNEE INSTABILITY AND PATELLAR CHONDROPATHY.

  Patient problems: Tissue Damage

  MAUDE report 10875437 ↗
• InjuryJul 1, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN 2 YEARS AND 2 MONTHS AFTER THE PRIMARY REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 17MM POLY WITH A 20MM POLY AND REVISED THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10218039 ↗
• InjuryMay 6, 2020Loose or Intermittent Connection

  REVISION SURGERY PLANNED AFTER 2 MONTHS FROM THE PRIMARY SURGERY DUE TO TIBIAL SUBSIDENCE AFTER A TIBIAL HEAD FRACTURE (THE CAUSE OF THE FRACTURE IS UNKNOWN). THE SURGEON REVISED THE INSERT AND TIBIAL TRAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10028338 ↗
• InjuryFeb 21, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PAIN ON THE TUBEROSITAS REGION. THE SURGEON DECIDED TO CHANGE THE TIBIAL PLATEAU 1 YEAR AND 9 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 9738113 ↗
• InjuryNov 27, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER 2 YEARS AND 11 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9382060 ↗
• InjurySep 24, 2019Migration; Migration

  THE PATIENT CAME IN DUE TO INSTABILITY CAUSED BY A SUBSIDED TIBIAL TRAY AFTER ABOUT 4 YEARS FROM THE PRIMARY. THE SURGEON REVISED THE TIBIAL TRAY AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109182 ↗
• InjuryAug 30, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 5 YEARS AND 2 MONTHS DUE TO PAIN CAUSED BY TIBIAL TRAY LOOSENING PROBABLY CAUSED BY A FALL. THE TIBIAL TRAY AND LINER HAVE BEEN REVISED.

  Patient problems: Joint Disorder

  MAUDE report 8948720 ↗
• InjuryNov 15, 2018Loose or Intermittent Connection

  ABOUT 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR TIBIAL PLATEAU LOOSENING. THE SURGEON SWAPPED SUCCESSFULLY THE TIBIAL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8073323 ↗