GMK Sphere Total Knee System 02.12.0210FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07630030826146), received between Aug 18, 2017 and May 8, 2026 — classified as 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 3 MONTHS FROM PRIMARY. REMOVAL OF THE INSERT, SYNOVECTOMY, CLEANSING, AND INSERTION OF A NEW INSERT.

  Patient problems: Medical device site infection

  MAUDE report 25123185 ↗
• InjuryJun 12, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY DUE TO METALLOSIS WITH LOOSENING OF THE KNEE SYSTEM AT ABOUT 2 YEARS. THE SURGEON REVISED ALL SYSTEM WITH COMPETITORS.

  Patient problems: Metal Related Pathology

  MAUDE report 22193763 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE 10MM SPHERE POLY WITH A 12MM E-CROSS POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20901406 ↗
• InjuryOct 24, 2024Naturally Worn; Naturally Worn

  REVISION SURGERY DUE TO KNEE INSTABILITY AT 5 YEARS AND 5 MONTHS FROM MEDACTA PRIMARY. FIBROUS TISSUE OBSERVED AND SUSPECTED TO BE DUE TO WEAR. POLY UPSIZED (FROM 10 TO 13 MM) AND PATELLA RESURFACED.

  Patient problems: Fibrosis; Joint Laxity

  MAUDE report 20522210 ↗
• InjuryJun 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 YEARS AND 7 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19603259 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO MILD LAXITY AND POOR PATELLA TRACKING. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE 10MM INSERT WITH AN 11MM INSERT AND REVISED THE PATELLA IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18453355 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND KNEE LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY (10 TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17955596 ↗
• InjuryAug 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17442756 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE LINER WAS REVISED WITH A THICKER ONE (FROM 10 TO 12MM) DUE TO INSTABILITY. DURING THE REVISION, THE TINBN-COATING OF THE FEMORAL COMPONENT WAS FOUND RUBBED OFF IN ONE CONDYLE. NO MATERIAL WAS FOUND BETWEEN THE FEMUR AND THE INSERT. THE FEMORAL COMPONENT WAS NOT REVISED. THE SURGEON PLANS TO REVISE THE PATIENT TO SWITCH TO A HINGE SYSTEM BECAUSE THE INSTABILITY PERSISTS.

  Patient problems: Joint Laxity

  MAUDE report 17077576 ↗
• InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available

  HOLD FOR KP 3.15THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND REVISED THEM WITH COMPETITOR COMPONENTS 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13769980 ↗
• InjuryFeb 18, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13558667 ↗
• InjuryMay 31, 2021Migration; Migration

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE TIBIAL INSERT SCREW HAD DISENGAGED AND ENDED UP INSIDE OF THE TISSUE. IT WAS ALSO OBSERVED THAT THE TIBIAL INSERT SCREW HAD CAUSED DAMAGE TO THE UNRESURFACED PATELLA. 4 YEARS AND 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE LINER, TIBIAL TRAY AND ADDED AN EXTENSION STEM AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. WHEN THE SURGEON OPERATED ON THE PATIENT, IT WAS OBSERVED THAT THE TIBIAL TRAY WAS ALSO LOOSE, SO THE SURGEON REVISED IT. A TORQUE LIMITING SCREWDRIVER WAS NOT USED DURING THE PRIMARY.

  Patient problems: Insufficient Information

  MAUDE report 11906932 ↗
• InjuryMay 17, 2021Loose or Intermittent Connection

  1 YEAR AND 1 MONTH THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND X-RAYS INDICATED THAT THE SCREW FROM THE POLY HAD LOOSENED. THE CAUSE OF THE LOOSENING OF THE SCREW IS UNKNOWN. THE SURGEON REMOVED THE SCREW AND DID NOT REVISE ANY IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11831975 ↗
• InjuryApr 28, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 11737284 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11154579 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem

  LINER REVISION AND WASHOUT PERFORMED 1 MONTH AFTER THE PRIMARY SURGERY DUE TO AN INFECTION (STAPHYLOCOCCUS). THE INSERT WAS EXCHANGED FOR ONE OF THE SAME SIZE.

  Patient problems: Bacterial Infection

  MAUDE report 11154510 ↗
• InjuryDec 1, 2020Appropriate Device Problem Term/Code Not Available

  TWO YEARS AND THREE MONTHS AFTER PRIMARY TOTAL KNEE, THE PATIENT COMPLAINED OF KNEE PAIN AND INSTABILITY. REVISION SURGERY HAS BEEN PERFORMED WITH INSERT EXCHANGED FROM THICKNESS 10MM TO 14MM.

  Patient problems: Joint Laxity

  MAUDE report 10926440 ↗
• InjuryNov 17, 2020Loosening of Implant Not Related to Bone-Ingrowth

  DURING THE STANDARD FOLLOW-UP CHECK, THE TIBIAL INSERT FIXATION SCREW WAS FOUND LOOSE IN THE JOINT. THE SCREW HAS BEEN ARTHROSCOPICALLY REVISED ON (B)(6) 2020, 4 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY. ON (B)(6) 2020 SOME TISSUE, THROUGH AN ARTHROSCOPIC PROCEDURE, HAS BEEN EXTRACTED TO CHECK IF THE PATIENT WAS SEPTIC. ON (B)(6) 2020 THEY CHANGED THE INLAY DUE TO SEPSIS.

  Patient problems: Sepsis

  MAUDE report 10852283 ↗
• InjuryNov 12, 2020Loose or Intermittent Connection; Unstable

  REVISION SURGERY PERFORMED, 1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY, DUE TO LAXITY AND INSTABILITY. NO TRAUMA, LOOSENING, PAIN REPORTED. LINER HAS BEEN SUCCESSFULLY REPLACED (FROM 10MM TO 14MM).

  Patient problems: Pain

  MAUDE report 10828489 ↗
• InjuryOct 19, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LOOSE LIGAMENTS. THE CAUSE OF THE LOOSE LIGAMENTS IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 10MM S2 TO A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 17MM 1 YEAR AND 1 MONTH AFTER SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10697598 ↗
• InjuryFeb 6, 2020Loose or Intermittent Connection

  A YEAR AND A HALF AFTER A SUCCESSFUL PRIMARY TOTAL KNEE, THE PATIENT COMPLAINT ON A ANTERIOR KNEE PAIN. THE SURGEON DECIDED TO RESURFACE THE PATELLA AND ACCORDING TO A LITTLE FLEXION LAXITY HE ALSO DECIDED TO REMOVE THE LINER AND TO CHANGE IT TO 12MM HEIGHT INSTEAD OF 10MM THAT WAS INSIDE.

  Patient problems: Joint Disorder

  MAUDE report 9676087 ↗
• MalfunctionMay 2, 2019Loose or Intermittent Connection

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO WILL NEED AN ARTHROSCOPIC REMOVAL OF THE INLAY LOCKING SCREW, AFTER ABOUT 4 YEARS FROM IMPLANTATION, DUE TO SCREW UNSCREWING. PATIENT IS NOT HAVING ANY PAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8573543 ↗
• MalfunctionApr 3, 2019Difficult to Insert; Difficult to Insert

  DURING THE PRIMARY KNEE SURGERY AND WHILE ATTEMPTING TO ENGAGE THE 10MM INSERT SCREW WITH THE TIBIAL TRAY, IT WAS DISCOVERED THAT SCREW WOULD NOT ENGAGE. AN 11MM INSERT WAS OPENED AND THE SCREW FROM THAT INSERT WAS USED IN THE 10MM INSERT WITH NO ISSUES. THIS CAUSED A 2-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478383 ↗
• InjuryJan 17, 2019Patient-Device Incompatibility

  REVISION SURGERY PERFORMED, 3 YEARS AND 2 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN. THE PATELLA WAS RESURFACED AND THE INSERT REVISED.

  Patient problems: Pain

  MAUDE report 8256604 ↗
• InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 WEEKS AFTER THE PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7837116 ↗