GMK Sphere Total Knee System 02.12.E0410FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 07630971261761), received between Sep 26, 2022 and Jul 8, 2026 — classified as 55 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (38 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGERY PERFORMED A WASHOUT, I&D, AND REVISED THE FLEX 4RINSERTFROM 10MM TO 11MM AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25747715 ↗
• InjuryJun 30, 2026Device Appears to Trigger Rejection

  AT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGERY PERFORMED A WASHOUT AND REVISED THE 10MM INSERT TO THE SAME-SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25663310 ↗
• InjuryMay 22, 2026Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS AFTER THE 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 25253487 ↗
• InjuryMay 20, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND 3 MONTHS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX4R - 10 MM INSERT TO A FLEX4R - 14 MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25230402 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MOTHS FROM PRIMARY THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE 4R - 10 MM INSERT TO A 4R - 11 MM INSERT AT HIS DISCRETION TO IMPROVE KNEE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25123208 ↗
• MalfunctionApr 15, 2026Use of Device Problem

  DURING THE PRIMARY RIGHT KNEE SURGERY, THE SURGEON WAS HAVING DIFFICULTY GETTING THE INSERT TO FIT INTO THE TIBIAL TRAY. THE SURGEON ATTEMPTED THE FORCE OF PUSH AND HITTING THE INSERT ONTO THE TRAY, BUT IT WOULD NOT SUCCESSFULLY SEAT. THE SURGEON USED A SCALPEL AND TRIMMED THE POSTERIOR LATERAL EDGE OF THE INSERT AND WAS THEN ABLE TO PUSH IT ONTO THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882488 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 10MM TO 13MM) TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24700707 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY IN THE RIGHT KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TO A GMK-HINGE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24558211 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND I&D, AND REVISED THE GMK-SPHERE INSERT 10MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24454908 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  AT2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24208581 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA BONE AS WELL AS UPSIZED THE INSERT (FROM 10 MM TO 12 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23836937 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PAIN DUE TORUPTURED EXTENSOR MECHANISM. SURGEON PERFORMED AN EXTENSOR MECHANISM REPAIR AND SWAPPED THE POLY TO ONE OF THE SAME SIZE. INFORMATION ON PRIMARY ARE UNKNOWN.

  Patient problems: Damage to Ligament(s)

  MAUDE report 23836921 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 2 YEARS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER (FROM 10 TO 13MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23669518 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON UPSIZED THE LINER (10 TO 14MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615340 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE POLY TO GIVE THE PATIENT MORE STABILITY (FROM 10 TO 11MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615338 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY KNEE SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASH OUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON UTILIZED THE DOUBLE-DAIR TECHNIQUE, A TWO-STAGE REVISION PROCEDURE FOR TREATING ACUTE PERIPROSTHETIC JOINT INFECTION PERFORMED WITHIN A FEW DAYS. AS PART OF THIS APPROACH, THE TIBIAL INSERT WAS REVISED DURING THE SECOND STAGE ON (B)(6) 2025, AS A PREVENTIVE MEASURE. FINAL INSERT HAS BEEN IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 23477187 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 1 MONTH FROM THE PRIMARY THE PATIENT CAME IN WITH AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23477173 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATELLA AND UPSIZED THE POLY FROM 10MM TO 11MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23291530 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 15 DAYS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 23093855 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED TO AN UPSIZED POLY (FROM 10 TO 11 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22991546 ↗
• InjuryAug 27, 2025Device 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 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22902787 ↗
• InjuryAug 8, 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 22749141 ↗
• InjuryJul 31, 2025Device 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 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22673491 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR POST PRIMARY THE SURGEON REVISED THE INSERT WITH ONE OF THE SAME THICKNESS AND RESURFACED THE PATIENT'S NATURAL PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22209904 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 1 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE INSERT (FROM 10MM TO 8MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 22042950 ↗