GMK Sphere Total Knee System 02.12.E0311FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630971261563), received between Sep 8, 2023 and Jun 9, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND STIFFNESS. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE FLEX 3R - 11MM INSERT TO A FLEX 3R - 10MM TO ADDRESS THE STIFFNESS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 25442546 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING SIGNS OF INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE LINER (11MM TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24710925 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT FROM AN 11MM TO A 14MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24376298 ↗
• InjurySep 12, 2025Device 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 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY, 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 23036823 ↗
• InjuryAug 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 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: Medical device site infection

  MAUDE report 22802871 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE POLY (FROM 11 TO 17MM) TO GIVE STABILITY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REVISION WAS NOT RELATED TO MEDACTA PRODUCTS/EFFECTIVENESS. THE PATIENT PRESENTED WITH POST OP PAIN AND INSTABILITY AND THE SURGEON SCHEDULED THIS AS AN EXPLORATORY SURGERY AND DECIDED TO EXCHANGE THE POLY WHILE HE WAS IN THERE.

  Patient problems: Joint Laxity

  MAUDE report 22345491 ↗
• InjuryNov 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, 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 20628496 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT (FROM 11 TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20555151 ↗
• InjuryJul 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF HIP INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19790167 ↗
• InjuryJun 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 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; Unspecified Infection

  MAUDE report 19468099 ↗
• InjuryApr 19, 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 PATELLA PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY AND PATELLA (SAME SIZE). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19143256 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS AN INSTABLE KNEE DUE TO LAXITY. AT 3 MONTHS POST PRIMARY THE SURGEON REVISED THE 11MM INSERT WITH A 14MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18464792 ↗
• InjurySep 8, 2023Adverse 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 PATELLA PAIN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA. MOREOVER, THE LINER HAS BEEN DOWNSIZED (FROM 11MM TO 10MM) DUE TO TIGHTNESS. THE CAUSES OF THE REPORTED ISSUES ARE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17709873 ↗