GMK Sphere Total Knee System 02.12.E0210FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630971261280), received between Dec 5, 2022 and Aug 11, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (15 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 16, 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.

• InjuryAug 11, 2026Device Appears to Trigger Rejection

  At about 2 months after the primary, the patient 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 50209581 ↗
• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 1 MONTH FROM THE PRIMARY DUE TO INFECTION.THE SURGEON REVISED THE INSERT TO THE SAME SIZE AS ONE.

  Patient problems: Medical device site infection

  MAUDE report 25838709 ↗
• InjuryJul 8, 2026Device Appears to Trigger Rejection

  AT ABOUT 8 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX 2R - 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25747723 ↗
• InjuryApr 14, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24871724 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 7 MONTHS POST PRIMARY THE SURGEON RESURFACED THE PATIENT`S NATURAL PATELLA AND UPSIZED THE LINER TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23837294 ↗
• InjuryNov 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON IMPLANTED ANTIBIOTIC SPACERS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23615351 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23579962 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A PATELLA TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON PREFORMED A POLY TENDON REPAIR AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PATELLA PAIN AND INSTABILITY, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA PATELLA WITH A COMPETITOR PATELLA AND UPSIZED THE POLY (FROM 10 TO 12 MM) TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 22902792 ↗
• InjuryJul 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE PRIMARY SURGERY 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 22664406 ↗
• InjuryJun 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT TWO MONTHS FROM 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: Medical device site infection

  MAUDE report 22343743 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH FROM 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: Medical device site infection

  MAUDE report 22147833 ↗
• InjuryMay 16, 2025Device 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 4 AND HALF MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22033728 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE INABILITY TO REACH FULL EXTENSION IN THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON EXPLANTED THE TIBIA AND POLYETHYLENE. HE DID A RE-CUT OF THE TIBIA AND PUT IN A SIZE 1 TIBIA WITH A 14 MM POLY THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21960296 ↗
• InjuryNov 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 5 MONTHS FROM 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 20722939 ↗
• InjuryNov 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT REPORTED PAIN DUE TO ADHESION AND SCAR TISSUE FORMATION AS WELL AS PATELLA DISCOMFORT. HAS BEEN ALSO REPORTED PRESENCE OF INSTABILITY. THE SURGEON REVISED THE FEMUR AND INSERT AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20630839 ↗
• InjuryOct 23, 2024Device 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: Medical device site infection; Unspecified Infection

  MAUDE report 20512685 ↗
• InjuryOct 16, 2024Adverse 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 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (FROM 10MM TO 12MM) AND RESURFACED THE NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20459598 ↗
• InjurySep 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 8 MONTHS FROM 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 20224335 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN SHOWING SIGNS OF QUAD EXTENSOR ISSUES AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (FROM 10 TO 11 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19517349 ↗
• InjuryMar 22, 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16590954 ↗
• InjuryMar 7, 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16494450 ↗
• InjuryDec 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15914679 ↗