GMK Sphere Total Knee System 02.12.E0510FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07630971262003), received between Oct 5, 2022 and Jul 22, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (29 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX 5R - 10MM INSERT TO A SAME SIZE INSERT.

  Patient problems: Medical device site infection

  MAUDE report 25904705 ↗
• InjuryJul 9, 2026Device Appears to Trigger Rejection

  REVISON SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT TO A SAME SIZE INSERT.

  Patient problems: Medical device site infection

  MAUDE report 25763496 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 9 MONTHS DUE TO KNEE INSTABILITY. THE SURGEON REVISED THE 10MM INSERT TO A 13MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25275470 ↗
• InjuryMay 15, 2026Device Appears to Trigger Rejection

  AT2 YEARS 2 MONTHS FROM MEDACTA PRIMARY SURGERY,THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX5R - 10MM INSERT TO A FLEX 5R 12MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25185361 ↗
• InjuryMay 8, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 YEARS AND 2 MONTHS FROM FIRST REVISION SURGERY (MDR 2024-00075). THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2023. THE SURGEON REMOVED THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25123207 ↗
• InjuryMay 8, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 5 MONTHS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 5R - 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25123171 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  AT 6 WEEKS FROM PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE 5R 10MM INSERT TO A 5R 11MM INSERT TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24924653 ↗
• InjuryApr 14, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM THE PRIMARY,THE PATIENT CAME IN PRESENTING SIGNS OF AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 10MM TIBIAL INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24871726 ↗
• InjuryMar 16, 2026Device Appears to Trigger Rejection

  PRIMARY SURGERY ON THE (B)(6) 2026 WITH GMK SPHERE SYSTEM. 1ST REVISION SURGERY ON THE (B)(6) 2026 FOR INFECTION (B)(4), LINER SWAP. 2ND REVISION SURGERY ON THE (B)(6) 2026 FOR INFECTION (STAPHYLOCOCCUS AUREUS). NO LOOSENING OF THE IMPLANTS, ONLY LINER SWAP.

  Patient problems: Medical device site infection

  MAUDE report 24603547 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  AT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER (FROM 10 TO 17 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24031971 ↗
• InjuryJan 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED ABOUT 20 DAYS AFTER THE PRIMARY SURGERY DUE TO INFECTION. THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24020871 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO KNEE INSTABILITY. THE SURGEON REVISED THE 10 MM INSERT TO A 14 MM INSERT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS.

  Patient problems: Joint Laxity

  MAUDE report 23920105 ↗
• InjuryDec 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 8 MONTHS FROM 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 23694047 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND UPSIZED THE INSERT FROM 10MM TO 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23461658 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN AND CAUSE IS UNKNOWN. THE SURGEON DETERMINED THE PATIENT HAD A SLIGHT FLEXION CONTRACTURE. AT ABOUT 1 YEAR AND 11 MONTHS POST PRIMARY THE SURGEON UPSIZED THE POLY, REVISED THE LINER FROM A 10MM TO AN 11MM WHILE REMOVING POSTERIOR OSTEOPHYTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 23436205 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (FROM 10 MM TO 13 MM) TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23349012 ↗
• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23290700 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A REVISION AND UPSIZED THE POLY FROM 10 MM TO 11 MM. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Joint Laxity

  MAUDE report 23070838 ↗
• InjurySep 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 MONTHS FROM 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 22961101 ↗
• InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD KNEE INFLAMMATION AND REDNESS. THE SURGEON DETERMINED THIS WAS DUE TO INFECTION WITH THE CAUSE UNKNOWN. AT ABOUT 10 MONTHS FORM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISION OF THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATHOGEN- CULTURE CAME BACK POSITIVE FOR STAPHYLOCOCCUS.

  Patient problems: Medical device site infection

  MAUDE report 22936792 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY. THE SURGEON UPSIZED THE POLY (10 TO 13MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22539657 ↗
• InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  FEW DAYS AFTER PRIMARY 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22061138 ↗
• InjuryMay 5, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS IN BOTH FLEXION AND EXTENSION. THE SURGEON PROCEEDED TO REMOVE THE INSERT AND TIBIAL TRAY. HE THEN MADE A RECUT OF THE TIBIA AND TRAILED WITH SPHERE TRIALS. ONCE THE KNEE WAS BALANCED HE IMPLANTED A CEMENTED TIBIA WITH A NEW INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21958375 ↗
• InjuryApr 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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 21928670 ↗
• InjuryApr 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. BETWEEN THE PRIMARY AND THE REVISION SURGERY, THE PATIENT SLIPPED WHILE ON HOLIDAYS IN ITALY, WHERE THE DOCTOR IN THE (B)(6) HOSPITAL PERFORMED A JOINT ASPIRATE.

  Patient problems: Medical device site infection

  MAUDE report 21736806 ↗