GMK Sphere Total Knee System 02.12.0211FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630030862540), received between Feb 1, 2018 and Feb 16, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 6 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE INSERT FROM 11MM TO 13MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24343888 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIX YEARS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH ANTERIOR KNEE PAIN, AND THE SURGEON IDENTIFIED KNEE LAXITY. DURING THE REVISION SURGERY, THE SURGEON UPSIZED THE INSERT FROM 11 MM TO 13 MM AND PERFORMED A PATELLAR RESURFACING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23299624 ↗
• InjuryDec 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE PE INLAY FROM THE TIBIAL BASEPLATE AT ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT CAME IN REPORTING PAIN WHEN FLEXING HIS KNEE. THE PATIENT'S REHABILITATION DID NOT PROCEED AS EXPECTED, CAUSING UNNECESSARY PAIN AND DISCOMFORT FOR FOUR MONTHS. THE HOSPITAL STAY WAS ALSO PROLONGED, AND THE HEALTH IMPACT ON THE PATIENT HAS BEEN SIGNIFICANT. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT APPEARS THAT THE INSERT MAY HAVE DISLOCATED POSTERIORLY FROM THE JOINT CAPSULE. THIS SUGGESTS THAT THE INSERT MIGHT NOT HAVE BEEN PROPERLY LOCKED DURING THE PROCEDURE. HOWEVER, DURING THE SURGERY, THE SURGEON HEARD THE "CLICK" SOUND INDICATING THE INSERT WAS SECURED, AND THE SURGEON CONFIRMED THAT THE ANTERIOR ASPECTS OF BOTH THE INSERT AND TIBIAL TRAY WERE PERFECTLY ALIGNED WITH NO GAPS. THEREFORE, THERE WAS NO ISSUE WITH THE HANDLING OF THE PRODUCT ITSELF.

  Patient problems: Joint Dislocation

  MAUDE report 20900792 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (11 MM) WITH A THICKER ONE (13 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19466533 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER (11 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17413516 ↗
• InjuryApr 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE WAS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE LINER (11MM) WITH A THICKER ONE (12MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16775054 ↗
• InjuryApr 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Unspecified Infection

  MAUDE report 16723124 ↗
• InjuryOct 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AND 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (11MM) WITH A THICKER ONE (17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15541783 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE GMK TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT AND CONVERTED IT TO A SPHERE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE LINER WITH A HIGHER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15501961 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13440311 ↗
• InjuryNov 23, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 11 MONTHS, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12860791 ↗
• InjuryNov 3, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12742989 ↗
• InjuryMay 11, 2021Loosening of Implant Not Related to Bone-Ingrowth

  1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S2 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S2R - 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11804174 ↗
• InjuryMay 4, 2021Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO INFECTION AFTER ABOUT 1 MONTH FROM THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT ALREADY UNDERWENT REVISION SURGERY, IT WAS DUE TO THE TIBIAL TRAY SUBSIDENCE, THIS HAPPENED ABOUT 1 MONTH AGO, WITH RESPECT TO THIS SURGERY. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT AND ADDED A FLUTED EXTENSION STEM AND TIBIAL AUGMENT.

  Patient problems: Unspecified Infection

  MAUDE report 11770208 ↗
• InjuryMar 2, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY THAT OCCURRED OVER TIME. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S2 WITH A SPHERE INSERT FLEX RIGHT 13MM S2 1 YEAR AND 2 MONTHS AFTER PRIMARY, TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11398441 ↗
• InjuryOct 27, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S2 WITH A SPHERE INSERT FLEX RIGHT 13MM S2 1 YEAR AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10741057 ↗
• InjuryJul 15, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY 4 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S2 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S2R - 17 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10275352 ↗
• InjuryFeb 26, 2020Unstable; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 11MM S2 WITH A MEDACTA SPHERE INSERT FLEX RIGHT 17MM S2 1 YEAR AND 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9756895 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 2 WEEKS FROM THE PRIMARY DUE TO SIGNS OF INFECTION (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 8703930 ↗
• InjuryAug 23, 2018Device Dislodged or Dislocated

  PATIENT PRESENTED 16 MONTHS POST SURGERY RIGHT TOTAL KNEE REPLACEMENT SPHERE KNEE. TIBIAL INSERT SCREW BACKOUT NOTED ON X RAY. PATIENT HAD SCREW REMOVED ARTHROSCOPICALLY UNDER A GENERAL ANAESTHETIC.

  Patient problems: No Code Available

  MAUDE report 7809075 ↗
• MalfunctionJun 15, 2018Mechanical Problem

  DURING SURGERY THE INSERT WOULD NOT SEAT PROPERLY IN THE TIBIAL IMPLANT. THE SURGEON USED A SECONDARY INSERT COMPLETING THE SURGERY SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605419 ↗
• InjuryFeb 1, 2018Contamination

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7233959 ↗