GMK Sphere Total Knee System 02.12.0026RRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030862441), received between Dec 15, 2017 and Jun 24, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Naturally Worn; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 9 YEARS AND 4 MONTHS FROM PRIMARY DUE TO PAIN AND STIFFNESS, CAUSING SAGITTAL INSTABILITY. THE SURGEON REMOVED THE SCAR TISSUE AND REVISED THE GMK-SPHERE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY TO A GMK-HINGE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT HAS BEEN REPORTED THAT THERE WERE SIGNS OF LYSIS ON THE POLYETHYLENE LINER. IT HAS BEEN HYPOTHESIZED THAT THE INSTABILITY HAVE CAUSED TIBIAL SUBSIDENCE AND SUCCESSIVE LYSIS OF THE WEAR.

  Patient problems: Loss of Range of Motion

  MAUDE report 25608881 ↗
• InjuryMay 27, 2026Osseointegration Problem

  REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE KNEE IMPLANTS AFTER ABOUT 9 YEARS AND 4 MONTHS FROM PRIMARY. THE SURGEON REVISED THE GMK-SPHERE PATELLA S4 TO A SAME SIZE PATELLA, REVISED THE SPHERE FEMUR CEMENTED RIGHT S6 + TO A GMK-HINGE FEMORAL COMPONENT SIZE 5, REVISED THE FLEX RIGHT 14MM S5 INSERT TO A GMK-HINGE SIZE5 12MM INSERT, AND REVISED THE GMK-SPHERE TIBIAL CEMENTED TRAY S5 TO A GMK-HINGE TIBIAL TRAY 5R. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25297689 ↗
• InjuryMay 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY, 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: Medical device site infection

  MAUDE report 19328371 ↗
• InjurySep 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, 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. ON (B)(6) 2022, 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. PRESENTLY, ON (B)(6) 2022, 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 15389618 ↗
• InjuryJul 13, 2021Appropriate Device Problem Term/Code Not Available

  THE SURGEON REVISED ALL IMPLANTS ON (B)(6) 2021 DUE TO INFECTION AND INSTALLED A CEMENT SPACER. ON (B)(6) 2021 THE SURGEON REMOVED THE CEMENT SPACER AND INSTALLED NEW IMPLANTS. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. THE PATIENT HAD PREVIOUSLY ((B)(6) 2020) A LINER REVISION AND WASHOUT ALSO DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12157568 ↗
• InjuryJun 7, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING DISCOMFORT AND TIGHTNESS IN THE KNEE AND THE CAUSE OF THE DISCOMFORT AND TIGHTNESS IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, AND ADDED AN EXTENSION STEM AND OFFSET CONNECTOR 2 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 11946022 ↗
• InjuryDec 20, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9502122 ↗
• InjuryDec 15, 2017Unstable

  THE PATIENT HAD A PRIMARY KNEE IMPLANT IN (B)(6) 2017. IN NOVEMBER THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON SCHEDULED A REVISION FOR (B)(6) 2017. MORE INFORMATION TO FOLLOW THE CASE.

  Patient problems: Joint Disorder

  MAUDE report 7121394 ↗