GMK Sphere Total Knee System 02.12.E0314FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630971261679), received between Sep 10, 2024 and Aug 3, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Device Appears to Trigger Rejection

  The patient had a primary knee surgery on (b)(6) 2019. On (b)(6) 2025, the patient had instability and a & quot; clicking & quot; noise in knee and the cause is unknown. There was no reports of trauma. The surgeon revised the Flex S3L - 10mm insert to a Flex 3L - 14mm insert. The surgery was completed successfully "[MDR 2026-00469]". On (b)(6) 2026, the patient had signs of an infection and the cause is unknown. The surgeon performed a washout and revised the GMK-SPHERE tibial insert E-Cross - Flex 3L - 14mm with a new GMK-SPHERE tibial insert E-Cross - Flex 3L - 14mm. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50114127 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING INSTABILITY, THE REASON IS UNKNOWN. AT ABOUT 1 YEAR AND 3 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE 14MM INSERT TO A 17MM INSERT, REVISED THE GMK-SPHERIKA S3 FEMORAL COMPONENT TO A GMK-REVISION S4 FEMORAL COMPONENT, AND REVISED THE PRIMAY L30MM EXTENSION STEM WITH A FLUTED L150MM EXTENSION STEM.

  Patient problems: Joint Laxity

  MAUDE report 25040713 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 2 WEEKS 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 23838610 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 1 MONTH 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 23579655 ↗
• InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LATERAL DISLOCATION. THE SURGEON REVISED TO A THICKER POLY, 14MM TO 20MM, AND USED SUTURES TO TIGHTEN THE LCL. THE SURGERY WAS COMPLETED SUCCESSFULLY

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22529149 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (FROM 14 TO 20 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20180516 ↗