GMK Sphere Total Knee System 02.12.0410FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 07630030826542), received between Jul 31, 2017 and May 26, 2026 — classified as 84 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (10 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 87 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD HIP INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 YEAR AND 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX S4R - 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25275474 ↗
• MalfunctionMay 13, 2026No Apparent Adverse Event

  THE 10 MM INSERT DID NOT ENGAGE WITH THE TIBIAL TRAY. A 14 MM INSERT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DELAY TIME WAS 30 MINUTES (TOTAL SURGERY TIME WAS 2.5 HOURS)DUE TO THE SURGEON`S ATTEMPTING TO PLACE THE INSERT ONTO THE TRAY MULTIPLE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160342 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT`S NATURAL PATELLA AND REVISED THE INSERT (10 MM TO 13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24924652 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOUR YEARS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH KNEE INSTABILITY. THE SURGEON UPSIZED THE INSERT FROM 10 MM TO 14 MM, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23669507 ↗
• InjuryJul 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE TIBIAL INSERT WAS REMOVED DUE TO INFECTION AND A WASHOUT WAS PERFORMED. THE SURGEON IMPLANTED A NEW INSERT OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22554192 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN.THE SURGEON PERFORMED A POLY SWAP, INCREASING THE SIZE FROM 10MM TO 20MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22505891 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 2 AND A HALF MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE LINER (FROM 10MM TO 12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22159531 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD STIFFNESS AND THE CAUSE IS UNKNOWN. AT ABOUT 3 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REMOVED SCAR TISSUE AND REVISED THE POLY PER STANDARD PROCEDURE, IMPLANTING ONE OF THE SAME THICKNESS. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED: 02.12.0410FR GMK-SPHERE TIBIAL INSERT - FLEX S4R - 10 MM 2309249.

  Patient problems: Joint Laxity

  MAUDE report 22010827 ↗
• InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY FOR LINER DISSOCIATION AT 3 MONTHS FROM PRIMARY. LINER SUCCESSFULLY REVISED (10 TO 14 MM).

  Patient problems: Joint Dislocation

  MAUDE report 21975205 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (13MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21772093 ↗
• InjuryMar 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2024, THE PATIENT UNDERWENT PRIMARY SURGERY WITH IMPLANTATION OF GMK-SPHERE COMPONENTS WITHOUT RESURFACING PATELLA. ON (B)(6) 2025, THE PATIENT CAME IN AND STAPHYLOCOCCUS EPIDERMIDIS INFECTION IS SUSPECTED. WOUND WITH DRAINAGE UP TO THE PROSTHESIS. NO LOOSENING OF THE COMPONENTS. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL INSERT.

  Patient problems: Medical device site infection

  MAUDE report 21606146 ↗
• InjuryFeb 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN COMPLAINING OF MID FLEXION INSTABILITY. THE SURGEON REVISED THE INSERT (10 MM TO 14 MM) AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21467672 ↗
• InjuryNov 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER 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 20731657 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 4 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE NATURAL PATELLA AND UPSIZED THE INSERT (FROM 10 TO 12MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20623473 ↗
• InjuryOct 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 YEARS AND 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND POSSIBLE LOOSENING OF JOINT STABILITY OVER TIME, WITH CONSEQUENT PATELLOFEMORAL PAIN. THE SURGEON REVISED SUCCESSFULLY THE LINER (10MM) WITH A THICKER ONE (13MM) AND RESURFACED PATIENT'S PATELLA BONE.

  Patient problems: Joint Laxity

  MAUDE report 20469755 ↗
• InjuryOct 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 5 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER FROM A 10MM TO 13MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20449841 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY 2 YEARS AND 1 MONTH AFTER THE PRIMARY. THE SURGEON UPSIZED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20124868 ↗
• InjuryAug 22, 2024Migration; Migration

  THE PATIENT HAD PAIN AND LIMITED RANGE OF MOTION, DUE TO THE SCREW DISASSOCIATING WITH THE POLY AND MIGRATING TO THE POSTERIOR CONDYLE. AT ABOUT 9 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON REMOVED THE SCREW AND REVISED THE 10MM POLY WITH ANOTHER 10MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT CONFIRMED THAT THE TORQUE LIMITING SCREWDRIVER WAS NOT UTILIZED IN THE PRIMARY SURGERY.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 20034475 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF PATELLO-FEMORAL DISSATISFACTION SINCE AFTER PRIMARY SURGERY. THE CAUSE OF THIS DISSATISFACTION IS UNKNOWN. THE SURGEON RESURFACED SUCCESSFULLY THE PATELLA BONE AND REVISED THE INSERT (10MM) WITH A THICKER ONE (11MM) TO GIVE THE PATIENT MORE STABILITY.

  Patient problems: Discomfort

  MAUDE report 19666931 ↗
• InjuryDec 22, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 YEARS AND 10 MONTHS AFTER PRIMARY, THE PATIENT WAS REVISED BECAUSE OF INSTABILITY. THE LINER WAS CHANGED WITH A THICKER ONE (10MM TO 14MM) AND PATELLAR BONE HAS BEEN RESURFACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18386908 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 YEARS AND 5 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 17904734 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (10 TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17834221 ↗
• InjurySep 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 11 MONTHS, 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 17717640 ↗
• InjuryJul 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER 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: Unspecified Infection

  MAUDE report 17342462 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING ANTERIOR PAIN AND INSTABILITY OF THE RIGHT KNEE. NO INFECTION. NO LOOSENING OF THE IMPLANTS. THE SURGEON REVISED SUCCESSFULLY THE INSERT (10MM) WITH A THICKER ONE (11MM).

  Patient problems: Implant Pain

  MAUDE report 16992798 ↗