GMK Sphere Total Knee System 02.12.0411CRRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040707503), received between Dec 22, 2021 and May 25, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2026Device Appears to Trigger Rejection

  THE PATIENT HISTORY WAS AS FOLLOWS: (B)(6) 2024: THE PATIENT PRESENTED WITH A PAINFUL SYNDROME ON THE ANTERIOR ASPECT OF THE RIGHT PROSTHETIC KNEE. (B)(6) 2024: A SECONDARY RESURFACING OF THE PATELLA WAS PERFORMED. (B)(6) 2026: SA SURGICAL DEBRIDEMENT OF THE INNER EDGE OF THE PATELLA WAS PERFORMED. (B)(6) 2026: THE PATIENT DEVELOPED AN ACUTE PERIPROSTHETIC SEPSIS WITH THE PRESENCE OF CITROBACTER FREUNDII; DURING THIS PROCEDURE, ONLY THE INSERT WAS REVISED. (B)(6) 2026: ANTIBIOTIC PRESCRIPTION (INFECTION TREATMENT) WITH NO REVISED PRODUCTS WE ARE WAITING FOR OUTCOMEE

  Patient problems: Medical device site infection

  MAUDE report 25268614 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 3 YEARS AND 7 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT (FROM 11 TO 13 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17247477 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (11 TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 17031356 ↗
• InjuryMar 19, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 WEEKS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13820199 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN ONE YEAR AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13059799 ↗