GMK Sphere Total Knee System 02.12.0217FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030826269), received between Nov 20, 2018 and Mar 8, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 4 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY WHERE IT WAS OBSERVED THAT THE PATIENT HAD A BONE SPUR (OSTEOPHYTES). THE SURGEON REMOVED THE BONE SPUR AND UPSIZED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13693112 ↗
• InjuryJul 15, 2021Appropriate Device Problem Term/Code Not Available

  2 MONTHS AFTER THE PRIMARY SURGERY 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 THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12171652 ↗
• InjuryFeb 16, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 2 MONTHS AFTER PREVIOUS REVISION SURGERY (PRIMARY IN 2018) DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL THE IMPLANTS EXCEPT THE PATELLA AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS THE 3RD REVISION SURGERY FOR THIS PATIENT. THE PREVIOUS REVISIONS WERE PERFORMED DUE TO QUAD TENDON REPAIR (INSET REVISED) AND INFECTION (WASHOUT AND INSERT REVISION).

  Patient problems: Unspecified Infection

  MAUDE report 11331084 ↗
• InjuryNov 20, 2018Microbial Contamination of Device

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 WEEK AFTER THE PRIMARY. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON PERFORMED AN I&D AND POLYSWAP.

  Patient problems: Unspecified Infection

  MAUDE report 8089810 ↗