GMK Sphere Total Knee System 02.12.E0414FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630971261914), received between Feb 10, 2022 and Aug 13, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Device Appears to Trigger Rejection

  Revision surgery after 7 months from primary due to infection. The surgeon revised the liner to the same size.

  Patient problems: Medical device site infection

  MAUDE report 50232826 ↗
• InjuryJul 17, 2026Device Dislodged or Dislocated

  PRIMARY SURGERY PERFORMED ON THE (B)(6) 2024. FIRST REVISION SURGERY PERFORMED ON THE (B)(6) 2026 DUE TO KNEE LAXITY. SECOND REVISION SURGERY PERFORMED ON THE (B)(6) 2026 DUE TO DISENGAGEMENT OF THE LINER FROM THE TIBIAL TRAY. EXPLANTATION OF THE LINER AND IMPLANTATION OF A TIBIAL INSERT FIXED SPHERE FLEX USING THE DEDICATED TORQUE LIMITER.

  Patient problems: Joint Dislocation

  MAUDE report 25854819 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER 7 MONTHS POST-PRIMARY DUE TOINFECTION, AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT TO THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24208607 ↗
• InjuryJan 8, 2026Device Appears to Trigger Rejection

  AT ABOUT 3 WEEKS FROM 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: Medical device site infection

  MAUDE report 24004453 ↗
• InjuryDec 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025 THE SURGEON REVISED THE POLY DUE TO INFECTION. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN.THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23886581 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN FOR ANTERIOR KNEE PAIN AROUND THE PATELLA AND JOINT INSTABILITY. POST OP IMAGING HAS CONFIRMED THAT THE BASE PLATE AND FEMUR ARE WELL FIXED AND THE SURGEON WANTS TO REPLACE THE 14MM INSERT WITH A 15.5MM. THE REVISION SURGERY IS NOT YET PLANNED AS A COMPASSIONATE USE SUBMISSION IS ON-GOING (IT WILL NOT START UNTIL (B)(6) 2024).

  Patient problems: Joint Laxity

  MAUDE report 21026665 ↗
• InjuryDec 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20900672 ↗
• InjuryOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TWO DAYS AFTER THE PRIMARY KNEE SURGERY, THE PATIENT HAS BEEN REVISED BECAUSE, THE DAY AFTER THE PRIMARY THE PATIENT PULLED HER KNEE IN AN ATTEMPT TO ACHIEVE MAXIMUM FLEXION AND KNEE LUXATION OCCURRED (FEMORAL COMPONENT FROM LINER). THE SURGEON REVISED ALL COMPONENTS TO GMK-HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20469761 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT ABOUT 1 MONTH FORM THE PRIMARY THE SURGEON REVISED THE 14MM POLY WITH A 20MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20028143 ↗
• InjuryFeb 22, 2023Adverse 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. ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (FROM 14 TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417782 ↗
• InjuryFeb 10, 2022Appropriate Device Problem Term/Code Not Available

  AT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN 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 13504883 ↗