GMK Sphere Total Knee System 02.12.E0411FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630971261792), received between Jul 28, 2023 and May 12, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY IN THE LEFT KNEE AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE 11MM INSERT TO 14MM INSERT TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25148935 ↗
• InjuryMar 10, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION 5 MONTHS AFTER PRIMARY SURGERY. THE PATIENT CAME IN SHOWING SIGNS OF ACUTE PROSTHETIC JOINT INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 11MM INSERT TO AN INSERT OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24558212 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  AT ABOUT 3 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 DURING THE PROCEDURE REVISED THE 11MM TIBIAL INSERT FROM THE PRIMARY SURGERY FOR A 14MM TIBIAL INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454897 ↗
• InjuryDec 5, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  AFTER 2 MONTHS POST-SURGERY, THE PATIENT CAME IN DUE TO INFECTION AND STIFFNESS, AND THE CAUSE IS UNKNOWN. THE SURGEON TOOK CULTURES TO TEST FOR INFECTION AND DOWNSIZED THE INSERT FROM 11 MM TO 10 MM. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 23725620 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 3 MONTHS POST PRIMARY, THE SURGEON UPSIZED THE LINER TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615342 ↗
• InjuryNov 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON ALSO FOUND SIGNS OF AN INFECTION, SO AT ABOUT 6 MONTHS POST PRIMARY HE PERFORMED A WASHOUT AND UPSIZED THE POLY FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 23615336 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER 1 YEAR AND 5 MONTHS FROM THE PRIMARY THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY FROM 11MM TO 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23310301 ↗
• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND REPORTING INSTABILITY. THE CAUSES OF THE INFECTION AND INSTABILITY ARE UNKNOWN. ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED TO A THICKER POLY, 11MM TO 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 22506332 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE STIFFNESS IN THE KNEE AND THE CAUSE OF THE STIFFNESS IS UNKNOWN. AT ABOUT 10 MONTHS POST PRIMARY THE SURGEON PERFORMED A SYNOVECTOMY AND DOWNSIZED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 22193038 ↗
• InjuryNov 22, 2024Device 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20755831 ↗
• InjuryNov 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A QUAD TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REPAIRED THE QUAD TENDON AND UPSIZED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, 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 20732105 ↗
• InjuryOct 24, 2024Device 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20522318 ↗
• InjuryOct 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR FROM 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 20409404 ↗
• InjuryOct 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF 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 20341814 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 7 MONTHS FROM PRIMARY THE SURGEON REVISED THE LINER IMPLANTING A 2MM THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED: 02.12.E0413FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 13MM 2249833.

  Patient problems: Joint Laxity

  MAUDE report 19381977 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE DUE TO SCAR TISSUE THAT HAD DEVELOPED. THE SURGEON CLEANED OUT THE SCAR TISSUE AND DOWNSIZED THE POLY (FROM 11 MM TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Scar Tissue

  MAUDE report 19309997 ↗
• InjuryMay 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING TIGHTNESS IN WHEN IN FLEXION AND THE CAUSE IS UNKNOWN. THE SURGEON RELEASED THE LIGAMENTS AND DOWNSIZED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19307464 ↗
• InjuryApr 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY DUE TO THE PATIENT'S NATURAL PATELLA SHIFTING LATERALLY. THE SURGEON RESURFACED THE NATURAL PATELLA AND UPSIZED THE POLY TO ADDRESS MINOR INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 19085956 ↗
• InjuryMar 15, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18911092 ↗
• InjuryJul 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 2 WEEKS FOR INFECTION THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17413824 ↗