GMK Sphere Total Knee System 02.12.0612FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030826986), received between Aug 25, 2017 and May 3, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 3, 2022Appropriate Device Problem Term/Code Not Available

  DUE TO INFECTION, A WASHOUT OF THE KNEE WAS PERFORMED AND INSERT WAS CHANGED, 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY. THE EXISTING SIZE 6 RIGHT 12MM INSERT WAS REMOVED AND REPLACED WITH A SIZE 6 RIGHT 14MM INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 14267206 ↗
• InjuryNov 17, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 13 DAYS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12826688 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem

  2 YEARS AND 4 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, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11795930 ↗
• InjuryJan 12, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN AFTER 1 YEAR AND 10 MONTHS REPORTING INSTABILITY, WHICH WAS DUE TO LAXITY. THE SURGEON REVISED THE 12MM INSERT WITH A 14MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11153446 ↗
• InjuryFeb 21, 2019Loose or Intermittent Connection; Unstable

  GMK REVISION PERFORMED 2 YEARS AFTER PRIMARY SURGERY, DUE TO INSTABILITY CAUSED BY LAXITY. THE SURGEON REVISED THE 12MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8357659 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY IN (B)(6) 2014. ON (B)(6) 2018 THE PATIENT WAS REVISED DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY (MDR 2018-00313). ON (B)(6) 2018 THE PATIENT WAS REVISED AGAIN DUE TO SIGNS OF INFECTION, THE SURGEON SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7734718 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7722404 ↗
• InjuryJul 26, 2018Insufficient Device Problem Information

  REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7722392 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information

  REVISION FOR POSSIBLE INFECTION. THE SURGEON REPLACED THE TIBIAL INSERT AND WENT UP FROM A 12MM POLY TO A 14MM POLY. HE FELT THE KNEE WAS MORE STABLE WITH A SLIGHTLY THICKER INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6819956 ↗