GMK Sphere Total Knee System 02.12.E0511FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630971262041), received between Sep 13, 2022 and Apr 14, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATING PATELLA AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON REVISED THE FEMORAL COMPONENT, THE TIBIAL TRAY, THE INSERT (FROM 11MM TO A SEMICONSTRAINED 14MM) AND THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 24871670 ↗
• InjuryMar 31, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 9MONTHS FROM THE PRIMARY,THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGERY REVISED THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT AND IMPLANTED ANTIBIOTIC SPACERS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24738819 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING KNEE LAXITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. AT ABOUT 10 MONTHS FROM PRIMARY THE SURGEON REVISED THE GMK-SPHERE 11MM INSERT TO A GMK-SPHERE 13MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24711330 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24208613 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  AFTER 1 YEAR AND 2 MONTHS FROM PRIMARY SURGERY, THE PATIENT PRESENTED WITH ANTERIOR KNEE PAIN AND INSTABILITY OF UNKNOWN CAUSE. DURING REVISION SURGERY, THE SURGEON RESURFACED THE PATIENT`S NATURAL PATELLA USING A COMPETITOR PATELLA AND UPSIZED THE LINER TO IMPROVE JOINT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24031943 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23615346 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 5 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 23477193 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Medical device site infection

  MAUDE report 23477189 ↗
• InjuryFeb 6, 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 INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (11 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21322089 ↗
• InjuryOct 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING TIGHTNESS AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY (FROM 11MM TO 10MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 20545159 ↗
• InjurySep 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 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20279279 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (11MM) WITH A THICKER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19656286 ↗
• InjuryJun 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 2 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 19557381 ↗
• InjuryMay 22, 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 OF THE INSTABILITY IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT (FROM 11 TO 13 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19369248 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH AND A HALF 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: Loss of Range of Motion

  MAUDE report 18817504 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING KNEE TIGHTNESS. THE SURGEON REVISED THE 11MM POLY WITH A 10MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 17395201 ↗
• InjuryMay 3, 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 2 MONTHS 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 16859032 ↗
• InjuryNov 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT FEW DAYS 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 15885768 ↗
• InjurySep 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 MONTH AND A HALF, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15409141 ↗