GMK Sphere Total Knee System 02.12.E0210FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630971261273), received between May 27, 2022 and Jul 9, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER 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-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L - 10MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25763491 ↗
• InjuryMar 26, 2026Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY LEFT KNEE SURGERY ON (B)(6) 2025 WITH GMK-SPHERIKA IMPLANTS AND A MOTO PATELLA. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO DISLOCATION OF THE PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A MANUAL LATERAL RELEASE AND TIGHTENED THE PATELLA WITH SUTURES. THE SURGERY ALSO REVISED THE POLY DURING THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY MDR (B)(4). ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING INSTABILITY DUE TO THE 10 MM TIBIAL INSERT NOT BEING FULLY ENGAGED (INTRA PROSTHETIC DISLOCATION). THE SURGEON REVISED THE 10 MM INSERT AND IMPLANTED A 14 MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24700710 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA, AND REVISED THE INSERT FROM 10MM TO AN 11MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24494912 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  AT ONE MONTH FROM PRIMARY, THE PATIENT CAME IN PRESENTING AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE POLY TO A POLY OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24208578 ↗
• InjuryDec 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS FROM PRIMARY THE PATIENT CAME IN DUE TO INFECTION. THE SURGEON PERFORMED A WASH OUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23920164 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (10 TO 12 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21958377 ↗
• InjuryDec 30, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT AROUND 1 YEAR AND 2 MONTHS, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21033802 ↗
• InjuryNov 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20746293 ↗
• InjuryOct 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 7 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 20425986 ↗
• InjuryJun 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 19517357 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND PATELLA BONE RESURFACING HAS BEEN PERFORMED. DURING THE REVISION, KNEE INSTABILITY HAS BEEN DETECTED AND FOR THIS REASON THE INSERT WAS REVISED (FROM 10MM TO 12MM). SLIGHT EXTERNAL ROTATION OF THE TIBIAL LBASEPLATE HAS BEEN OBSERVED, BUT IT IS UNKNOWN IF THIS CONTRIBUTED TO THE INSTABILITY. BECAUSE OF THE SATISFACTION OF KINEMATIC ALIGNMENT OF THE KNEE WITH THE HIGHER LINER AND PATELLA IMPLANT, NO FURTHER IMPLANTS WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18701847 ↗
• MalfunctionMay 27, 2022Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO ANTERIOR DISLOCATION OF THE POLY FROM THE TIBIAL TRAY, WHICH OCCURRED WHEN THE PATIENT WAS GETTING UP FROM A SEATED POSITION. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND POLY 2 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14521358 ↗