GMK Sphere Total Knee System 02.12.0311CRRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040707367), received between Jul 21, 2022 and Nov 10, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO FEELING TIGHTNESS AND A LIMITED RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A PCL RELEASE, SYNOVECTOMY, AND POLY-SWAP (FROM 11 MM TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 18109428 ↗
• InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING DIFFICULTY WITH FLEXION MOBILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON RELEASED THE PCL AND REVISED THE INSERT (FROM 11 TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 15864348 ↗
• InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 10 DAYS FROM PRIMARY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15074641 ↗