GMK Sphere Total Knee System 02.12.0513FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030862670), received between Oct 31, 2017 and Dec 6, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18272864 ↗
• InjuryJul 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION, THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17395196 ↗
• InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14346309 ↗
• InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 3 MONTHS AFTER THE PRIMARY SURGERY, 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 13769989 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 6 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10926402 ↗
• InjuryJul 30, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10343415 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN AFTER 5 MONTHS FROM THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED SPACER WITH ANTIBIOTIC CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9989994 ↗
• InjuryFeb 24, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY NEEDED AFTER 10 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9744764 ↗
• InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 10 DAYS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8615716 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 2 MONTHS FROM THE PRIMARY FOR INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8478379 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY IN (B)(6) 2015. IN (B)(6) 2015 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON IRRIGATED AND DEBRIDED THE KNEE AND REPLACED THE LINER (B)(4). ON (B)(6) 2018 THE PATIENT WAS REVISED DUE TO SIGNS OF INFECTION 2 YEARS AND 9 MONTHS AFTER THE PREVIOUS SURGERY. THE SURGEON SWAPPED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7453594 ↗
• InjuryMar 29, 2018Appropriate Device Problem Term/Code Not Available

  EIGHTEEN DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INFECTION. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7380660 ↗
• InjuryDec 6, 2017Contamination

  ONE MONTH AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT INLAY FOR INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7086825 ↗
• InjuryOct 31, 2017Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON REVISED THE SIZE 5/13 MM POLY FOR A SIZE 5/17 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6990382 ↗