GMK Sphere Total Knee System 02.12.E0514FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630971262164), received between Aug 29, 2023 and Mar 16, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO EXCESSIVE FLUID ON HIS KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA TO A COMPETITOR IMPLANT, AND REVISED THE 14MM INSERT TO A 17MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24603554 ↗
• InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN FOR AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE TIBIAL INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23334289 ↗
• InjuryAug 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 2021-00034 WAS SENT. ON (B)(6) 2023 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 2023-00620 WAS SENT. PRESENTLY, ON (B)(6) 2025, 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 22768916 ↗
• InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 WEEKS FROM PRIMARY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22541079 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT (14MM) WITH A THICKER ONE (20MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22076617 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE LATERAL INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 3 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE LINER WITH A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21918630 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A PATELLA TENDON REPAIR AND REVISED THE INSERT (WITH ONE OF THE SAME THICKNESS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17640799 ↗