GMK Sphere Total Knee System 02.12.E0310FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630971261525), received between Sep 19, 2023 and Aug 3, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Device Appears to Trigger Rejection

  At 6 weeks 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 to a liner of the same size. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50114123 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 11 MONTHS AFTER PRIMARY DUE TOINSTABILITY IN FLEXION AND THE CAUSE IS UNKNOWN. NO TRAUMA WAS REPORTED. THE SURGEON REVISED THE INSERT FROM A 10MM TO A 14MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24826106 ↗
• InjuryFeb 16, 2026Device Appears to Trigger Rejection

  AT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT TO AN INSERT OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24343898 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT (FROM 10 MM TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24020873 ↗
• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23850109 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ONE MONTH POST THE PRIMARY SURGERY, THE PATIENT REPORTED AN INFECTION OF UNKNOWN CAUSE. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT.

  Patient problems: Medical device site infection

  MAUDE report 23836927 ↗
• InjurySep 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23081549 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22991530 ↗
• InjuryAug 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 2 WEEKS FROM PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. AFTER THE WASHOUT, THE SURGEON DECIDED TO REVISE THE LINER TO ACHIEVE MORE STABILITY (FROM 10 TO 11 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 22922922 ↗
• InjuryDec 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20877877 ↗
• InjuryOct 16, 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 20464712 ↗
• InjurySep 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH 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: Unspecified Infection

  MAUDE report 20235662 ↗
• InjuryMar 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY AND PATELLA RESURFACING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18844188 ↗
• InjuryFeb 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND HALF POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18657204 ↗
• InjuryJan 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 2 MOTHS FROM THE PRIMARY FOR 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 18585790 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PATELLA PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND SWAPPED THE POLY (FROM 10 MM TO 12 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18084567 ↗
• InjurySep 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 2 WEEKS 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: Unspecified Infection

  MAUDE report 17773618 ↗