GMK Sphere Total Knee System 02.12.0212FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030826184), received between Jul 25, 2017 and Aug 27, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22901809 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 10 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN DUE TO A LOOSE PATELLA IMPLANT. THE SURGEON REVISED THE PATELLA IMPLANT WITH A COMPETITOR'S PRODUCT AND REVISED THE 12MM MEDACTA INSERT WITH A 13MM MEDACTA INSERT, DUE TO GLOBAL LAXITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 18333478 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR KNEE INSTABILITY AT ABOUT 4 YEARS AND 7 MONTHS POST-PRIMARY. LINER WAS REVISED SUCCESSFULLY WITH A THICKER ONE (FROM 12MM TO 17MM).

  Patient problems: Joint Laxity

  MAUDE report 17161348 ↗
• InjuryOct 11, 2022Adverse 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 1 YEAR AND 5 MONTHS, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE (FROM 12 TO 13 MM), AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15575843 ↗
• InjuryJul 27, 2021Migration; Migration

  5 YEARS AND 3 MONTHS AFTER PRIMARY REVISION SURGERY FOR LINER FIXATION SCREW UNSCREWING. LINER REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12231414 ↗
• InjuryAug 3, 2020Migration; Migration

  THE PATIENT CAME IN 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A SCREW FROM THE TIBIAL INSERT HAD LOOSENED. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10354785 ↗
• InjuryJul 1, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION OF A GMK SPHERE PROSTHESIS 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO LAXITY (SPECIALLY IN FLEXION). THE SURGEON REVISED THE INLAY AND CHANGE TO A 14MM INLAY.

  Patient problems: Joint Disorder

  MAUDE report 10217919 ↗
• InjuryFeb 11, 2019Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 10 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE POLY, 12 MM, WITH A THICKER IMPLANT, 14 MM. THE TIBIAL TRAY WAS REVISED AS WELL, EXTENSION STEM AND AUGMENTION WERE USED IN THE REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8325131 ↗
• InjuryJul 18, 2018Device Slipped

  THE SCREW HAD BACKED OUT AND GOT LODGED BETWEEN THE POLY AND THE FEMORAL COMPONENT 1 YEAR AFTER PRIMARY. THE SURGEON REMOVED THE SCREW AND THE POLY, DID AN EXTENSIVE DEBRIDEMENT, TRIALED DIFFERENT SIZE POLY AND DECIDED TO GO FROM A 12 TO A 14MM POLY. THE FEMUR, TIBIA AND PATELLA WERE ALL WELL FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7698440 ↗
• InjuryMay 29, 2018Defective Component

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ABOUT TWO YEARS AFTER PRIMARY. THE SURGEON NOTICED A DEFECT UNDER THE TIBIAL IMPLANT WHICH THE SURGEON PACKED WITH ANTIBIOTIC BEADS. THE SURGEON PERFORMED AN I & D AND A POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATHOGEN WAS STAPHYLOCOCCUS.

  Patient problems: Unspecified Infection

  MAUDE report 7549096 ↗
• InjuryMay 23, 2018Unintended Movement

  ON (B)(6) 2018 WE WERE INFORMED THAT A PATIENT HAD PRESENTED TO CLINIC WITH ANTERIOR KNEE PAIN. X RAY SHOWED PARTIAL BACK OUT OF THE TIBIAL INSERT SCREW. ON (B)(6) 2018 SURGEON ARTHROSCOPIC REMOVED THE INLAY LOCKING SCREW DUE TO UNSCREWING.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7536828 ↗
• InjuryJul 25, 2017Device Issue; Device Issue

  THE PATIENT CAME IN COMPLAINING OF DISCOMFORT. THE SURGEON TOOK X-RAYS WHICH REVEALED LOOSE SCREW. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 6740146 ↗