GMK Sphere Total Knee System 02.12.0214FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030826221), received between Sep 7, 2018 and Dec 18, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 3 YEARS AND 9 MONTHS POST PRIMARY THE SURGEON UPSIZED THE LINER TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23837301 ↗
• InjuryJul 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT HAS UNDERGONE A UKA IN 2012 WITH COMPETITOR COMPONENTS. ON THE(B)(6) 2022, THE PATIENT HAS BEEN REVISED BECAUSE OF A FALL WHICH HAD PARTIALLY AFFECTED THE INTERNAL LATERAL LIGAMENT AND THE STABILITY OF THE PROSTHESIS. IMPLANTATION OF GMK-SPHERE COMPONENTS WITH MYKNEE CUTTING GUIDES. ON THE (B)(6) 2024, THE PATIENT HAS BEEN REVISED DUE TO INSTABILITY OF THE KNEE WITHOUT LOOSENING OF THE IMPLANTS. COMPLETE RUPTURE OF THE INTERNAL LATERAL LIGAMENT WAS DETECTED. THE PATIENT DID NOT MENTION A FALL. NO INFECTION. THE SURGEON REVISED THE TIBIAL INSERT (14MM) WITH A THICKER ONE (17MM) AND A SUTURE OF THE INTERNAL LATERAL LIGAMENT HAS BEEN PERFORMED. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19728254 ↗
• InjuryMar 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (14 TO 20 MM) AND RESURFACED THE NATURAL PATELLA TO HELP WITH TRACKING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18844186 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER (14MM) WITH A THICKER ONE (20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17904923 ↗
• InjuryJan 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2016. SUBSEQUENTLY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT, REPORTING PAIN AFTER FALLING. THE SURGEON OBSERVED THAT THE PATIENT HAD A LOOSE AND SUBSIDED TIBIA. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT ON (B)(6) 2022. PRESENTLY, AT ABOUT 11 MONTHS FROM PRIMARY THE PATIENT CAME IN 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 16102247 ↗
• InjuryDec 1, 2020Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE PATIENT ALSO REPORTED ANTERIOR KNEE PAIN AND THE CAUSE OF THE ANTERIOR KNEE PAIN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED THE GMK-SPHERE TIBIAL INSERT - FLEX S2R - 14MM, AND UPSIZED IT TO A GMK-SPHERE TIBIAL INSERT - FLEX S2R - 17 MM, TO HELP ALLEVIATE THE ANTERIOR KNEE PAIN 1 YEAR AND 1 MONTH AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10928278 ↗
• InjuryMar 10, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY IN THE KNEE. THE SURGEON REVISED THE MEDACTA SPHERE INSERT FLEX RIGHT 14MM S2 WITH THE MEDACTA SPHERE INSERT FLEX RIGHT 20MM S2. TO TIGHTEN THE KNEE 10 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9811087 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY-SWAP 19 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9308981 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 11 DAYS AFTER THE PRIMARY SURGERY (PATHOGEN UNKNOWN). THE SURGEON PERFORMED AND I&D AND POLY SWAP AND THE SURGERY WAS PERFORMED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8184347 ↗
• InjurySep 7, 2018Unintended Movement

  ABOUT 1 YEAR AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR INLAY FIXATION SCREW UNSCREWING. INSERT REVISED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 7854956 ↗