GMK Sphere Total Knee System 02.12.E0310FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630971261518), received between Aug 30, 2022 and Jun 17, 2026 — classified as 19 injuries.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER 20 DAYS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED 10MM FLEX 3L - E-CROSS INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25528749 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THERE WAS NO REPORTS OF TRAUMA. THE SURGEON REVISED THE 10MM INSERT TO A 12MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25230403 ↗
• InjuryMay 12, 2026Device Appears to Trigger Rejection

  AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERIKA COMPONENTS TO GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148965 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND UPSIZED THE LINER (FROM 10 TO 13 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23837304 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO 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 23510666 ↗
• InjuryMay 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AT ABOUT 5 MONTHS FROM PRIMARY, DURING A POSTOP APPOINTMENT, THE PATIENT REPORTED PAIN. THE PATIENT SHOWED UNDEFINED COMPLICATION ON THE TIBIA SIDE. CURRENTLY IT IS NOT KNOWN WHETHER A REVISION SURGERY WILL BE PERFORMED.

  Patient problems: Pain

  MAUDE report 22084131 ↗
• InjuryMay 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO KNEE INFECTION, THE PATHOGEN IS UNKNOWN. AT ABOUT 10 MONTHS FROM PRIMARY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22009957 ↗
• InjuryMar 10, 2025Device 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 21558756 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO EXPERIENCING RECURVATUM STANDING UP. THE SURGEON UPSIZED THE POLY (FROM 10 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21353071 ↗
• InjuryFeb 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM 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 21320664 ↗
• InjuryNov 22, 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. ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20758451 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING KNEELING MOVEMENTS APPROACHING 90º OF FLEXION, AN ABNORMAL POSTERIOR TRANSLATION OF THE TIBIA IS OBSERVED WHEN THE HAMSTRINGS ARE ACTIVATED. FOLLOWING THIS TRANSLATION, THE RANGE OF MOTION (ROM) RETURNS TO NORMAL WITHOUT ANY FURTHER ABNORMAL MOVEMENT.

  Patient problems: Joint Laxity

  MAUDE report 20451649 ↗
• InjurySep 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH ONE OF THE SAME SIZE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20298884 ↗
• InjurySep 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A SEPTIC KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT (FROM 10 TO 11 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20117923 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S NATURAL PATELLA AND REVISED THE LINER (10MM) WITH A THICKER ONE (13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19836132 ↗
• InjuryMay 16, 2024Device 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 19328733 ↗
• InjuryFeb 27, 2024Adverse 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. AT ABOUT 1 YEAR POST-PRIMARY THE SURGEON UPSIZED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18788785 ↗
• InjuryAug 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17662154 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY. THE PATELLA WAS ALSO DISLOCATED AND IT WAS FIXED WITH SOFT TISSUE REPAIR. THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15319890 ↗