GMK Sphere Total Knee System 02.12.0417FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030826665), received between Nov 18, 2019 and Sep 11, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A RETINACULAR TEAR. THE SURGEON UPSIZED THE POLY AND RESURFACED THE PATELLA. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON DECIDED TO REVISE ALL THE IMPLANTS. THIS BECAUSE THE PATIENT IS A FALL RISK, WHICH MEAN THAT SHE DOES NOT WALK WELL OVERALL BECAUSE OF DIFFERENT SENSORY BRAIN FACTORS SUCH AS DIZZINESS OR NOT GREAT BALANCE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20188926 ↗
• InjuryAug 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PRIMARY KNEE SURGERY WAS ON (B)(6)2021. ON (B)(6)2023, THE PATIENT CAME IN REPORTING INSTABILITY. THE CAUSE OF THE INSTABILITY WAS DUE TO A RETINACULAR TEAR. THE SURGEON UPSIZED THE POLY AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6)2023, 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 17446910 ↗
• InjuryJan 18, 2022Appropriate Device Problem Term/Code Not Available

  AT 1 MONTH AND 12 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13280939 ↗
• InjuryNov 18, 2019Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY PERFORMED 9 MONTHS AFTER THE FIRST REVISION SURGERY DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A NEW FEMUR AND INSERT TO ACT AS A SPACER. THE FIRST REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION (INSERT REVISED).

  Patient problems: Unspecified Infection

  MAUDE report 9334341 ↗