GMK Sphere Total Knee System 02.12.E0412FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630971261846), received between Apr 5, 2023 and Aug 13, 2026 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Device Appears to Trigger Rejection

  At about 5 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 Flex 4R - 12mm insert to a same size insert. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50232824 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS 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 FLEX 4R - 12MM INSERT TO A FLEX4R - 13MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25442535 ↗
• InjuryMay 5, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER WITH A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25077223 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  ABOUT 1 YEAR AFTER PRIMARY SURGERY THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND SLIGHT INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND UPSIZED THE INSERT FROM 12MM TO 14MM.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24603555 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 2 YEARS 2 MONTHS AFTER THE PRIMARY DUE TO PAIN AND INSTABILITY. THE SURGEON PERFORMED RESURFACING OF THE PATELLA BONE AND REPLACEMENT OF THE TIBIAL INSERT (12 TO 14 MM).

  Patient problems: Joint Laxity

  MAUDE report 24276572 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN. THE SURGEON RESURFACED THE PATIENT`S NATURAL PATELLA BONE AND UPSIZED THE INSERT FROM 12MM TO 13MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 24208597 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 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 23477191 ↗
• InjuryMay 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 2 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 22078239 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING TIGHTNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S NATURAL PATELLA AND DOWNSIZED THE POLY (12 TO 11 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21354702 ↗
• InjuryDec 2, 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 3 WEEKS 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 20819131 ↗
• InjuryAug 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 12 DAYS FROM 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: Medical device site infection; Unspecified Infection

  MAUDE report 20021770 ↗
• InjuryJun 4, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER. ON (B)(6) 2024, 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 19457186 ↗
• InjuryFeb 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ABOUT 1 MONTH AND A HALF 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: Medical device site infection

  MAUDE report 18701123 ↗
• InjuryOct 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 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 18001770 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY (FROM 12MM TO 10MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 17867049 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16681949 ↗