GMK Sphere Total Knee System 02.12.0517FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030826863), received between Sep 25, 2018 and Jan 7, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE INSERT (17MM) WITH A THINNER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21093043 ↗
• InjuryApr 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE INSERT SCREW HAD BACKED OUT. IT IS UNKNOWN WHY THIS OCCURRED. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THE TORQUE LIMITER WAS USED DURING PRIMARY SURGERY TO PLACE THE SCREW INTO THE LINER.

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

  MAUDE report 19049344 ↗
• InjuryDec 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND INSERTED ANTIBIOTIC BEADS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, ANOTHER WASHOUT AND POLY-SWAP WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 18272886 ↗
• InjuryApr 20, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY WAS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S5R - 14 MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5R - 17 MM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14157895 ↗
• InjuryNov 23, 2021Unstable

  AT 2 WEEKS AFTER THE LAST 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 AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT HAD A LINER UPSIZED DUE TO KNEE INSTABILITY.

  Patient problems: Unspecified Infection

  MAUDE report 12859340 ↗
• InjurySep 25, 2018Insufficient Device Problem Information

  ON (B)(6) 2018 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER. THE PATHOGEN IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2018 AND A FIRST REVISION ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 7905438 ↗