GMK Sphere Total Knee System 02.12.T4I3RRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030827167), received between Jul 20, 2018 and May 8, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 4 YEARS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF CEMENTED TIBIAL TRAY LOOSENING. NO FEMORAL COMPONENT LOOSENING AND NO INFECTION DETECTED. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY AND TIBIAL INSERT.

  Patient problems: Aseptic loosening

  MAUDE report 21985052 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A CAPSULE TEAR, DISLOCATED PATELLA, AND SUBSIDED FEMUR. THE CAUSE OF THIS WAS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND IMPLANTED AN ANTIBIOTICS SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16814940 ↗
• InjuryNov 11, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LOOSENING OF THE KNEE COMPONENTS. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15778666 ↗
• InjurySep 21, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS EXCEPT THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15461309 ↗
• InjuryFeb 25, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2020. THEN, ON (B)(6) 2020, THE LINER WAS REVISED FOLLOWING AN INFECTION. PRESENTLY, ON (B)(6) 2021 (4 MONTHS AFTER PREVIOUS SURGERY), THE PATIENT CAM IN REPORTING PAIN AND INSTABILITY DUE TO A LOOSE TIBIAL COMPONENT. THE CAUSE OF THE LOOSE TIBIAL COMPONENT IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY, AS WELL AS ADDED AUGMENTS AND EXTENSION STEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11377458 ↗
• InjuryJan 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN AND LIMITED RANGE OF MOTION, WHICH WAS CAUSED BY A LOOSE TIBIAL COMPONENT. THE SURGEON REVISED THE MEDACTA TIBIAL COMPONENT, FEMORAL COMPONENT AND POLY WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 11129984 ↗
• InjuryMar 14, 2019Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO NEEDED A REVISION 4 YEARS AND 6 MONTHS AFTER THE PRIMARY DUE TO INFECTION (THE PATHOGEN IS UNKNOWN). ON THE FOLLOWING DAY THE TIBIAL TRAY, INSERT AND FEMORAL COMPONENT HAVE BEEN REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 8420921 ↗
• MalfunctionMar 13, 2019Improper or Incorrect Procedure or Method

  ONE OF THE SURGEON TECH MADE A MISTAKE IN A SURGERY BY GIVING THE SURGEON A TIBIAL COMPONENT T4-I3 FOR FEMORAL COMPONENT 4. THE PATIENT HAS BEEN INFORMED TO HAVE A TIBIAL COMPONENT T4-I3, INSERT 3 AND FEMORAL COMPONENT 4. THE SURGEON WILL FOLLOW THE PROGRESSION OF THIS PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8416474 ↗
• InjuryAug 22, 2018Unintended Movement

  THE TIBIAL TRAY WAS FOUND INTERNALLY ROTATED 8 MONTHS AFTER PRIMARY. SURGEON PLANNED TO TAKE IT OUT AND REALIGN THE BASE PLATE FOR BETTER KNEE ALIGNMENT. DURING REVISION THE SURGEON SUSPECTED INFECTION AS THERE WAS SYNOVIAL FLUID BEHIND THE CEMENT. THE FEMORAL BONE WAS ALSO REALLY SOFT. HE DECIDED TO DO A 2 STAGE REVISION: ALL THE IMPLANTS WERE REMOVED AND THE SPECIMENS SENT FOR ANALYSIS. HE TEMPORARILY PUT THE FEMUR BACK IN WITH ANTIBIOTIC CEMENT AND CEMENTED (TEMPORARILY) THE POLY. THE SURGEON ALSO VOICED THAT THE FEMUR COMPONENT SEEMED MORE INTERNALLY ROTATED AND THE TIBIAL COMPONENT ALSO MALROTATED.

  Patient problems: Unspecified Infection

  MAUDE report 7804986 ↗
• InjuryJul 20, 2018Appropriate Device Problem Term/Code Not Available

  DUE TO MALPOSITIONING OF IMPLANTS (PRIMARILY FEMORAL COMPONENT, BUT ALSO TIBIAL COMPONENT), THE PATIENT SUFFERED RESIDUAL PAIN AND NEEDED A REVISION 1 YEAR AND 8 MONTHS AFTER REVISION.

  Patient problems: Pain

  MAUDE report 7706402 ↗