GMK Sphere Total Knee System 02.12.0314FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030826412), received between Jul 11, 2018 and Jun 26, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF ACUTE PERIPROSTHETIC JOINT INFECTION AND THE PATHOGEN IS BACTEREMIA. THE SURGEON PERFORMED A TRIPLE WASHOUT AND REVISED THE LINER FROM A 14MM FLEX S3L TO A 17MM FLEX 3L AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25632987 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT 2 MONTHS AND A HALF, THE SURGEON REVISED THE 14MM POLY WITH A 20MM POLY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16067302 ↗
• InjuryFeb 18, 2022Unstable

  REVISION SURGERY PERFORMED 6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY DUE TO INSTABILITY. THE SURGEON REVISED THE LINER WITH A THICKER ONE.

  Patient problems: Joint Laxity

  MAUDE report 13558668 ↗
• InjuryNov 30, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY PERFORMED AFTER 6 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY ON THE RIGHT SIDE DUE TO STEM LOOSENING. THE STEM WAS REVISED TO QUADRA C,

  Patient problems: Failure of Implant

  MAUDE report 10919035 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10918062 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 4 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10800516 ↗
• InjuryAug 28, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY INSERT 1 YEAR AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8938862 ↗
• InjuryJul 30, 2018Unstable

  ABOUT 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A MINOR KNEE INSTABILITY. ONLY LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7731844 ↗
• InjuryJul 11, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7677480 ↗